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1. Standardisation and consensus guidelines for minimal residual disease assessment in Philadelphia-positive acute lymphoblastic leukemia (Ph + ALL) by real-time quantitative reverse transcriptase PCR of e1a2 BCR-ABL1

Author

Pfeifer, H., Cazzaniga, G., van der Velden, V. H. J., Cayuela, J. M., Schäfer, B., Spinelli, O., Akiki, S., Avigad, S., Bendit, I., Borg, K., Cavé, H., Elia, L., Reshmi, S. C., Gerrard, G., Hayette, S., Hermanson, M., Juh, A., Jurcek, T., Chillón, M. C., Homburg, C., Martinelli, G., Kairisto, V., Lange, T., Lion, T., Mueller, M. C., Pane, F., Rai, L., Damm-Welk, C., Sacha, T., Schnittger, S., Touloumenidou, T., Valerhaugen, H., Vandenberghe, P., Zuna, J., Serve, H., Herrmann, E., Markovic, S., Dongen, J. J. M. van, and Ottmann, O. G.

Published
2019
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2. Correction: Standardisation and consensus guidelines for minimal residual disease assessment in Philadelphia-positive acute lymphoblastic leukemia (Ph+ALL) by real-time quantitative reverse transcriptase PCR of e1a2 BCR-ABL1

Author

Pfeifer, H., Cazzaniga, G., van der Velden, V. H. J., Cayuela, J. M., Schäfer, B., Spinelli, O., Akiki, S., Avigad, S., Bendit, I., Borg, K., Cavé, H., Elia, L., Reshmi, S. C., Gerrard, G., Hayette, S., Hermanson, M., Juh, A., Jurcek, T., Chillón, M. C., Homburg, C., Martinelli, G., Kairisto, V., Lange, T., Lion, T., Mueller, M. C., Pane, F., Rai, L., Damm-Welk, C., Sacha, T., Schnittger, S., Touloumenidou, T., Valerhaugen, H., Vandenberghe, P., Zuna, J., Serve, H., Herrmann, E., Markovic, S., van Dongen, J. J. M., and Ottmann, O. G.

Published
2020
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3. Correction: Standardisation and consensus guidelines for minimal residual disease assessment in Philadelphia-positive acute lymphoblastic leukemia (Ph+ALL) by real-time quantitative reverse transcriptase PCR of e1a2 BCR-ABL1 (Leukemia, (2019), 33, 8, (1910-1922), 10.1038/s41375-019-0413-0)

Author

Pfeifer H., Pfeifer, H, Cazzaniga, G, van der Velden, V, Cayuela, J, Schafer, B, Spinelli, O, Akiki, S, Avigad, S, Bendit, I, Borg, K, Cave, H, Elia, L, Reshmi, S, Gerrard, G, Hayette, S, Hermanson, M, Juh, A, Jurcek, T, Chillon, M, Homburg, C, Martinelli, G, Kairisto, V, Lange, T, Lion, T, Mueller, M, Pane, F, Rai, L, Damm-Welk, C, Sacha, T, Schnittger, S, Touloumenidou, T, Valerhaugen, H, Vandenberghe, P, Zuna, J, Serve, H, Herrmann, E, Markovic, S, van Dongen, J, Ottmann, O, Pfeifer H., Cazzaniga G., van der Velden V. H. J., Cayuela J. M., Schafer B., Spinelli O., Akiki S., Avigad S., Bendit I., Borg K., Cave H., Elia L., Reshmi S. C., Gerrard G., Hayette S., Hermanson M., Juh A., Jurcek T., Chillon M. C., Homburg C., Martinelli G., Kairisto V., Lange T., Lion T., Mueller M. C., Pane F., Rai L., Damm-Welk C., Sacha T., Schnittger S., Touloumenidou T., Valerhaugen H., Vandenberghe P., Zuna J., Serve H., Herrmann E., Markovic S., van Dongen J. J. M., Ottmann O. G., Pfeifer H., Pfeifer, H, Cazzaniga, G, van der Velden, V, Cayuela, J, Schafer, B, Spinelli, O, Akiki, S, Avigad, S, Bendit, I, Borg, K, Cave, H, Elia, L, Reshmi, S, Gerrard, G, Hayette, S, Hermanson, M, Juh, A, Jurcek, T, Chillon, M, Homburg, C, Martinelli, G, Kairisto, V, Lange, T, Lion, T, Mueller, M, Pane, F, Rai, L, Damm-Welk, C, Sacha, T, Schnittger, S, Touloumenidou, T, Valerhaugen, H, Vandenberghe, P, Zuna, J, Serve, H, Herrmann, E, Markovic, S, van Dongen, J, Ottmann, O, Pfeifer H., Cazzaniga G., van der Velden V. H. J., Cayuela J. M., Schafer B., Spinelli O., Akiki S., Avigad S., Bendit I., Borg K., Cave H., Elia L., Reshmi S. C., Gerrard G., Hayette S., Hermanson M., Juh A., Jurcek T., Chillon M. C., Homburg C., Martinelli G., Kairisto V., Lange T., Lion T., Mueller M. C., Pane F., Rai L., Damm-Welk C., Sacha T., Schnittger S., Touloumenidou T., Valerhaugen H., Vandenberghe P., Zuna J., Serve H., Herrmann E., Markovic S., van Dongen J. J. M., and Ottmann O. G.

Abstract

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Published
2020

4. Standardisation and consensus guidelines for minimal residual disease assessment in Philadelphia-positive acute lymphoblastic leukemia (Ph + ALL) by real-time quantitative reverse transcriptase PCR of e1a2 BCR-ABL1

Author

Pfeifer, H, Cazzaniga, G, van der Velden, V, Cayuela, J, Schäfer, B, Spinelli, O, Akiki, S, Avigad, S, Bendit, I, Borg, K, Cavé, H, Elia, L, Reshmi, S, Gerrard, G, Hayette, S, Hermanson, M, Juh, A, Jurcek, T, Chillón, M, Homburg, C, Martinelli, G, Kairisto, V, Lange, T, Lion, T, Mueller, M, Pane, F, Rai, L, Damm-Welk, C, Sacha, T, Schnittger, S, Touloumenidou, T, Valerhaugen, H, Vandenberghe, P, Zuna, J, Serve, H, Herrmann, E, Markovic, S, Dongen, J, Ottmann, O, Pfeifer, H., Cazzaniga, G., van der Velden, V. H. J., Cayuela, J. M., Schäfer, B., Spinelli, O., Akiki, S., Avigad, S., Bendit, I., Borg, K., Cavé, H., Elia, L., Reshmi, S. C., Gerrard, G., Hayette, S., Hermanson, M., Juh, A., Jurcek, T., Chillón, M. C., Homburg, C., Martinelli, G., Kairisto, V., Lange, T., Lion, T., Mueller, M. C., Pane, F., Rai, L., Damm-Welk, C., Sacha, T., Schnittger, S., Touloumenidou, T., Valerhaugen, H., Vandenberghe, P., Zuna, J., Serve, H., Herrmann, E., Markovic, S., Dongen, J. J. M. van, Ottmann, O. G., Pfeifer, H, Cazzaniga, G, van der Velden, V, Cayuela, J, Schäfer, B, Spinelli, O, Akiki, S, Avigad, S, Bendit, I, Borg, K, Cavé, H, Elia, L, Reshmi, S, Gerrard, G, Hayette, S, Hermanson, M, Juh, A, Jurcek, T, Chillón, M, Homburg, C, Martinelli, G, Kairisto, V, Lange, T, Lion, T, Mueller, M, Pane, F, Rai, L, Damm-Welk, C, Sacha, T, Schnittger, S, Touloumenidou, T, Valerhaugen, H, Vandenberghe, P, Zuna, J, Serve, H, Herrmann, E, Markovic, S, Dongen, J, Ottmann, O, Pfeifer, H., Cazzaniga, G., van der Velden, V. H. J., Cayuela, J. M., Schäfer, B., Spinelli, O., Akiki, S., Avigad, S., Bendit, I., Borg, K., Cavé, H., Elia, L., Reshmi, S. C., Gerrard, G., Hayette, S., Hermanson, M., Juh, A., Jurcek, T., Chillón, M. C., Homburg, C., Martinelli, G., Kairisto, V., Lange, T., Lion, T., Mueller, M. C., Pane, F., Rai, L., Damm-Welk, C., Sacha, T., Schnittger, S., Touloumenidou, T., Valerhaugen, H., Vandenberghe, P., Zuna, J., Serve, H., Herrmann, E., Markovic, S., Dongen, J. J. M. van, and Ottmann, O. G.

Abstract

Minimal residual disease (MRD) is a powerful prognostic factor in acute lymphoblastic leukemia (ALL) and is used for patient stratification and treatment decisions, but its precise role in Philadelphia chromosome positive ALL is less clear. This uncertainty results largely from methodological differences relating to the use of real-time quantitative PCR (qRT-PCR) to measure BCR-ABL1 transcript levels for MRD analysis. We here describe the first results by the EURO-MRD consortium on standardization of qRT-PCR for the e1a2 BCR-ABL1 transcript in Ph + ALL, designed to overcome the lack of standardisation of laboratory procedures and data interpretation. Standardised use of EAC primer/probe sets and of centrally prepared plasmid standards had the greatest impact on reducing interlaboratory variability. In QC1 the proportion of analyses with BCR-ABL1/ABL1 ratios within half a log difference were 40/67 (60%) and 52/67 (78%) at 10 −3 and 36/67 (53%) and 53/67 (79%) at 10 −4 BCR-ABL1/ABL1. Standardized RNA extraction, cDNA synthesis and cycler platforms did not improve results further, whereas stringent application of technical criteria for assay quality and uniform criteria for data interpretation and reporting were essential. We provide detailed laboratory recommendations for the standardized MRD analysis in routine diagnostic settings and in multicenter clinical trials for Ph + ALL.

Published
2019

5. Standardisation and consensus guidelines for minimal residual disease assessment in Philadelphia-positive acute lymphoblastic leukemia (Ph+ALL) by real-time quantitative reverse transcriptase PCR of e1a2 BCR-ABL1 (vol 32, pg 345, 2019)

Author

Pfeifer, H., Cazzaniga, G., Velden, V.H.J. van der, Cayuela, J.M., Schafer, B., Spinelli, O., Akiki, S., Avigad, S., Bendit, I., Borg, K., Cave, H., Elia, L., Reshmi, S.C., Gerrard, G., Hayette, S., Hermanson, M., Juh, A., Jurcek, T., Chillon, M.C., Homburg, C., Martinelli, G., Kairisto, V., Lange, T., Lion, T., Mueller, M.C., Pane, F., Rai, L., Damm-Welk, C., Sacha, T., Schnittger, S., Touloumenidou, T., Valerhaugen, H., Vandenberghe, P., Zuna, J., Serve, H., Herrmann, E., Markovic, S., Dongen, J.J.M. van, and Ottmann, O.G.

Abstract

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Published
2020

6. Standardisation and consensus guidelines for minimal residual disease assessment in Philadelphia-positive acute lymphoblastic leukemia (Ph plus ALL) by real-time quantitative reverse transcriptase PCR of e1a2 BCR-ABL1

Author

Pfeifer, H., Cazzaniga, G., van der Velden, V. H. J., Cayuele, J. M., Schafer, B., Spinelli, O., Akiki, S., Avigad, S., Bendit, I, Borg, K., Cave, H., Elia, L., Reshmi, S. C., Gerrard, G., Hayette, S., Hermansson, Monica, Juh, A., Jurcek, T., Chillon, M. C., Homburg, C., Martinelli, G., Kairisto, V, Langen, T., Lion, T., Mueller, M. C., Pane, F., Rai, L., Damm-Welk, C., Sacha, T., Schnittger, S., Touloumenidou, T., Valerhaugen, H., Vandenberghe, P., Zuna, J., Server, H., Herrmann, E., Markovic, S., van Dongen, J. J. M., Ottmann, O. G., Pfeifer, H., Cazzaniga, G., van der Velden, V. H. J., Cayuele, J. M., Schafer, B., Spinelli, O., Akiki, S., Avigad, S., Bendit, I, Borg, K., Cave, H., Elia, L., Reshmi, S. C., Gerrard, G., Hayette, S., Hermansson, Monica, Juh, A., Jurcek, T., Chillon, M. C., Homburg, C., Martinelli, G., Kairisto, V, Langen, T., Lion, T., Mueller, M. C., Pane, F., Rai, L., Damm-Welk, C., Sacha, T., Schnittger, S., Touloumenidou, T., Valerhaugen, H., Vandenberghe, P., Zuna, J., Server, H., Herrmann, E., Markovic, S., van Dongen, J. J. M., and Ottmann, O. G.

Abstract

Minimal residual disease (MRD) is a powerful prognostic factor in acute lymphoblastic leukemia (ALL) and is used for patient stratification and treatment decisions, but its precise role in Philadelphia chromosome positive ALL is less clear. This uncertainty results largely from methodological differences relating to the use of real-time quantitative PCR (qRT-PCR) to measure BCR-ABL1 transcript levels for MRD analysis. We here describe the first results by the EURO-MRD consortium on standardization of qRT-PCR for the e1a2 BCR-ABL1 transcript in Ph + ALL, designed to overcome the lack of standardisation of laboratory procedures and data interpretation. Standardised use of EAC primer/probe sets and of centrally prepared plasmid standards had the greatest impact on reducing interlaboratory variability. In QC1 the proportion of analyses with BCR-ABL1/ABL1 ratios within half a log difference were 40/67 (60%) and 52/67 (78%) at 10(-3) and 36/67 (53%) and 53/67 (79%) at 10(-4)BCR-ABL1/ABL1. Standardized RNA extraction, cDNA synthesis and cycler platforms did not improve results further, whereas stringent application of technical criteria for assay quality and uniform criteria for data interpretation and reporting were essential. We provide detailed laboratory recommendations for the standardized MRD analysis in routine diagnostic settings and in multicenter clinical trials for Ph + ALL.

Published
2019
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7. Minimal residual disease quantification by flow cytometry provides reliable risk stratification in T-cell acute lymphoblastic leukemia

Author

Modvig, S., Madsen, H. O., Siitonen, S. M., Rosthoj, S., Tierens, A., Juvonen, V, Osnes, L. T. N., Valerhaugen, H., Hultdin, M., Thorn, I, Matuzeviciene, R., Stoskus, M., Marincevic, M., Fogelstrand, L., Lilleorg, A., Toft, N., Jonsson, O. G., Pruunsild, K., Vaitkeviciene, G., Vettenranta, K., Lund, B., Abrahamsson, J., Schmiegelow, K., Marquart, H. , V, Modvig, S., Madsen, H. O., Siitonen, S. M., Rosthoj, S., Tierens, A., Juvonen, V, Osnes, L. T. N., Valerhaugen, H., Hultdin, M., Thorn, I, Matuzeviciene, R., Stoskus, M., Marincevic, M., Fogelstrand, L., Lilleorg, A., Toft, N., Jonsson, O. G., Pruunsild, K., Vaitkeviciene, G., Vettenranta, K., Lund, B., Abrahamsson, J., Schmiegelow, K., and Marquart, H. , V

Abstract

Minimal residual disease (MRD) measured by PCR of clonal IgH/TCR rearrangements predicts relapse in T-cell acute lymphoblastic leukemia (T-ALL) and serves as risk stratification tool. Since 10% of patients have no suitable PCR-marker, we evaluated flowcytometry (FCM)-based MRD for risk stratification. We included 274 T-ALL patients treated in the NOPHO-ALL2008 protocol. MRD was measured by six-color FCM and real-time quantitative PCR. Day 29 PCR-MRD (cut-off 10−3) was used for risk stratification. At diagnosis, 93% had an FCM-marker for MRD monitoring, 84% a PCR-marker, and 99.3% (272/274) had a marker when combining the two. Adjusted for age and WBC, the hazard ratio for relapse was 3.55 (95% CI 1.4–9.0, p = 0.008) for day 29 FCM-MRD ≥ 10−3and 5.6 (95% CI 2.0–16, p = 0.001) for PCR-MRD ≥ 10−3 compared with MRD < 10−3. Patients stratified to intermediate-risk therapy on day 29 with MRD 10−4–<10−3 had a 5-year event-free survival similar to intermediate-risk patients with MRD < 10−4 or undetectable, regardless of method for monitoring. Patients with day 15 FCM-MRD < 10−4 had a cumulative incidence of relapse of 2.3% (95% CI 0–6.8, n = 59). Thus, FCM-MRD allows early identification of patients eligible for reduced intensity therapy, but this needs further studies. In conclusion, FCM-MRD provides reliable risk prediction for T-ALL and can be used for stratification when no PCR-marker is available.

Published
2019
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