Trial record 1 of 1 for:    CALGB 8461
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Cytogenetic Studies in Acute Leukemia and Multiple Myeloma

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00048958
First received: November 12, 2002
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

Chromosomal analysis or the study of genetic differences in patients previously untreated with AML, ALL, MDS or MM may be helpful in the diagnosis and classification of disease. It may also improve the ability to predict the course of disease and the selection of therapy. Institutions must have either an Alliance-approved cytogeneticist or an agreement from an Alliance-approved main member cytogenetics laboratory to enroll a patient on CALGB 8461. The Alliance Approved Institutional Cytogeneticists list is posted on the Alliance for Clinical Trials in Oncology website.


Condition Intervention
Acute Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome
Multiple Myeloma
Genetic: cytogenetic analysis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Cytogenetic Studies in Acute Leukemia and Multiple Myeloma: Companion to CALGB Treatment Studies For Previously Untreated Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS) or Multiple Myeloma (MM) Patients

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Determine the incidence of specific less common primary as well as common secondary chromosome abnormalities in adult AML, ALL, MDS and MM [ Time Frame: Up to the time of relapse ] [ Designated as safety issue: No ]
  • Correlate specific (normal or various primary and secondary chromosomal abnormalities) with clinical and laboratory parameters [ Time Frame: Up to the time of relapse ] [ Designated as safety issue: No ]
  • Correlate specific karyotype groups with response rates, response duration, survival and cure in patients treated with various induction and post-induction regimens [ Time Frame: Up to the time of relapse ] [ Designated as safety issue: No ]
  • Correlate specific karyotype groups with selected molecular abnormalities as studied in CALGB leukemia protocols [ Time Frame: Up to the time of relapse ] [ Designated as safety issue: No ]
  • To correlate specific karyotype groups with multidrug resistance data [ Time Frame: Up to the time of relapse ] [ Designated as safety issue: No ]
  • To correlate specific karyotype groups with epidemiologic data (toxic exposure and family history) [ Time Frame: Up to the time of relapse ] [ Designated as safety issue: No ]
  • To determine karyotype changes at relapse and the influence of the type of change (or no change) in karyotype at relapse on subsequent clinical course [ Time Frame: Up to the time of relapse ] [ Designated as safety issue: No ]
  • To identify new chromosome abnormalities important in leukemogenesis [ Time Frame: Up to the time of relapse ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Institutions must submit patient samples (eg, bone marrow and peripheral blood) at diagnosis, at complete remission, and at the time of relapse to the Alliance-Approved Institutional Cytogeneticist.


Estimated Enrollment: 9000
Study Start Date: June 1984
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No treatment
Samples as defined per the protocol for previously untreated patients with AML, ALL, MDS or MM will be submitted for analysis and within one month patients are required to register onto a CALGB treatment study.
Genetic: cytogenetic analysis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient population from the clinical oncology research community including academic institutions, hospitals and clinics.

Criteria
  1. Patients from adjuncts are eligible if the Main Member Cytogenetics laboratory has agreed to process samples from that adjunct.
  2. Within one month of registration on CALGB 8461, register onto a CALGB treatment study for previously untreated AML, ALL, MDS, or MM patients.
  3. Simultaneously with registration on CALGB 8461, register patients within the continental United States onto CALGB 9665 (LTB).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048958

Contacts
Contact: Lisa Sterling, RHIA 614 688-9750 lisa.sterling@osumc.edu

  Show 137 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Clara Bloomfield, MD James Cancer Hospital and Solove Research Institute
  More Information

Publications:
Blum W, Mrozek K, Ruppert AS, et al.: Early allogeneic transplantation for adults with de novo acute myeloid leukemia presenting with t(6;11)(q27;q23): results from CALGB 8461. [Abstract] J Clin Oncol 22 (Suppl 14): A-6543, 568s, 2004.
Farag SS, Archer KJ, Mrózek K, et al.: Pre-treatment cytogenetics predict complete remission and long-term outcome in patients (Pts) ≥60 years with acute myeloid leukemia (AML): results from Cancer and Leukemia Group B (CALGB) 8461. [Abstract] Blood 104 (11): A-568, 2004.
Marcucci G, Mrózek, K, Ruppert AS, et al.: t(8;21) Acute myeloid leukemia (AML) differs from inv(16) AML in pretreatment characteristics, outcome and prognostic factors predicting outcome: a Cancer and Leukemia Group B (CALGB) Study. [Abstract] Blood 104 (11): A-2017, 2004.
Marcucci G, Mrózek K, Ruppert AS, et al.: Association of abnormal cytogenetics at date of morphologic complete remission (CR) with overall (OS), disease-free survival (DFS) and higher relapse rate in acute myeloid leukemia (AML): results from Cancer and Leukemia Group B (CALGB) 8461. [Abstract] J Clin Oncol 22 (Suppl 14): A-6514, 561s, 2004.
Slovak ML, Bloomfield CD, Gundacker H, et al.: Acute myeloid leukemia (AML) with t(6;9)(p23;q34) defines a very poor risk leukemia subgroup with distinguishing clinicopathological features: a United States (US) Cytogenetics Intergroup Study of 62 AML and MDS cases. [Abstract] Blood 104 (11): A-567, 2004.
Bloomfield CD, Byrd JC, Farag SS, et al.: Cytogenetics for treatment stratification in adult acute myeloid leukemia (AML). [Abstract] Ann Hematol 80 (Suppl 2): A-37, S10, 2001.
Byrd JC, Mrózek K, Dodge R, et al.: Pre-treatment cytogenetics predict initial induction success and overall survival in adult patients with de novo acute myeloid leukemia: results from CALGB 8461. [Abstract] Blood 98 (11 Pt 1): A-1912, 457a, 2001.
Farag SS, Archer KJ, Carroll AJ, et al.: Isolated trisomy (IT) is an adverse prognostic factor in patients (pts) with AML: results from Cancer and Leukemia Group B (CALGB 8461). [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1124, 2001.
Marcucci G, Archer KJ, Mrózek K, et al.: Abnormal karyotype during complete remission (CR) predicts short relapse-free survival (RFS) in acute myeloid leukemia (AML): results from CALGB 8461. [Abstract] Blood 98 (11 Pt 1): A-2421, 577a, 2001.
Wetzler M, Dodge RK, Mrozek K, et al.: Secondary chromosome aberrations in adult acute lymphoblastic leukemia (ALL) with t(9;22) - a Cancer and Leukemia Group B (CALGB) study. [Abstract] Blood 98 (11 Pt 1): A-466, 111a, 2001.
Wetzler M, Dodge RK, Mrózek K, et al.: Karyotype change in adult acute myeloid leukemia (AML) at first relapse - CALGB 8461. [Abstract] Blood 96 (11 Pt 1): A-3046, 706a, 2000.
Bloomfield D: Adult acute myeloid leukemia (AML) patients (PTS) with t(8;21)(q22;q22) have a superior outcome when repetitive cycles of high-dose cytarabine (HDAC) are administered. [Abstract] Ann Hematol 78 (Suppl 2): A-50, S13, 1999.
Byrd JC, Dodge R, Carroll A, et al.: Adult acute myeloid leukemia (AML) patients (PTS) with t(8;21)(q22;q22) have a superior outcome when repetitive cycles of high-dose cytarabine (HDAC) are administered. [Abstract] Blood 92 (10 Pt 1): A-1282, 312a, 1998.
Wetzler M, Dodge RK, Mrózek K, et al.: Trisomy 8 represents a poor risk group in adult acute lymphoblastic leukemia (ALL): results from Cancer and Leukemia Group B (CALGB) 8461. [Abstract] Blood 92 (10 Pt 1): A-914, 223a, 1998.
Mrózek K, Heinonen K, Lawrence D, et al.: t(9;11)(p22;q23) confers better prognosis than other translocations of 11q23 in adults with de novo acute myeloid leukemia (AML): a Cancer and Leukemia Group B study. [Abstract] Cytogenet Cell Genet 77: A-P332, 136, 1997.
Byrd JC, Lawrence D, Arthur DC, et al.: Acute myeloid leukemia (AML) patients with pre-treatment isolated trisomy 8 are rarely cured with chemotherapy: results of CALGB 8461. [Abstract] Proc Am Assoc Cancer Res 37: A-1286, 188, 1996.
Caligiuri MA, Strout MP, Arthur DC, et al.: Rearrangement of ALL1 is a recurrent molecular defect in adult acute myeloid leukemia (AML) with normal cytogenetics that predicts a short complete remission (CR) duration. [Abstract] Proceedings of the American Society of Clinical Oncology 15: A-1060, 1996.
Heinonen K, Mrózek K, Lawrence D, et al.: Trisomy 11 as the sole karyotypic abnormality identifies a group of older patients with acute myeloid leukemia (AML) with FAB M2 or M1 and unfavorable clinical outcome. Results of CALGB 8461. [Abstract] Proc Am Assoc Cancer Res 37: A-1275, 186-7, 1996.
Slack JL, Arthur DC, Lawrence D, et al.: Secondary (2°) cytogenetic changes in acute promyelocytic leukemia (APL): prognostic importance and association with the intron 3 breakpoint of the PML gene. [Abstract] Proc Am Assoc Cancer Res 37: A-3815, 557, 1996.
Mrozek K, Carroll AJ, Maharry K, et al.: Central review of cytogenetics is essential for cooperative group clinical and correlative studies of acute leukemia: The Cancer and Leukemia Group B (CALGB) 8461 experience. [Abstract] Blood 104 (11): A-1081, 2004.

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00048958     History of Changes
Other Study ID Numbers: CALGB-8461, NCI-2009-00494, CDR0000256897, 3U24CA114725-09S1
Study First Received: November 12, 2002
Last Updated: October 9, 2014
Health Authority: United States: NCI Central Institutional Review Board

Additional relevant MeSH terms:
Acute Disease
Leukemia
Leukemia, Lymphoid
Multiple Myeloma
Myelodysplastic Syndromes
Neoplasms, Plasma Cell
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Preleukemia
Syndrome
Blood Protein Disorders
Bone Marrow Diseases
Cardiovascular Diseases
Disease
Disease Attributes
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Pathologic Processes
Precancerous Conditions
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014