NCT00053196|CompletedPhase 2

Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Cancer

Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation For Patients With Disease Relapse Or Myelodysplasia After Prior Autologous Transplantation

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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3 other identifiers

CALGB-100002U10CA031946CDR0000269301

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJan 2003

StartedDec 2002

CompletionAug 2010

Brief Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving immunosuppressive therapy after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor bone marrow or peripheral stem cell transplant works in treating patients with relapsed hematologic cancer after treatment with chemotherapy and autologous stem cell transplant.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_2 leukemia

Timeline

Completed

Started Dec 2002

Typical duration for phase_2 leukemia

Geographic Reach

1 country

12 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.7 years study duration

Study Start

First participant enrolled

December 1, 2002

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2003

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2003

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed

3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed

Last Updated

July 1, 2016

Status Verified

June 1, 2016

Enrollment Period

3.9 years

First QC Date

January 27, 2003

Last Update Submit

June 30, 2016

Conditions

Leukemia Lymphoma Multiple Myeloma Plasma Cell Neoplasm Myelodysplastic Syndromes Myeloproliferative Neoplasms

Keywords

refractory chronic lymphocytic leukemiaprolymphocytic leukemiarecurrent adult Hodgkin lymphomastage I multiple myelomastage II multiple myelomastage III multiple myelomarefractory multiple myelomapreviously treated myelodysplastic syndromesrecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Burkitt lymphomarecurrent adult immunoblastic large cell lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomasecondary myelodysplastic syndromesde novo myelodysplastic syndromesrecurrent adult acute myeloid leukemiarecurrent childhood acute myeloid leukemiarecurrent childhood large cell lymphomarecurrent childhood lymphoblastic lymphomarecurrent childhood small noncleaved cell lymphomarecurrent/refractory childhood Hodgkin lymphomaatypical chronic myeloid leukemia, BCR-ABL negativemyelodysplastic/myeloproliferative neoplasm, unclassifiablerecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomaadult acute myeloid leukemia with t(8;21)(q22;q22)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with t(15;17)(q22;q12)childhood myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

Treatment-related mortality
6 months post transplant

Secondary Outcomes (4)

Per cent donor chimerism
30, 60, 90, 180 days post transplant
Disease-free survival
12 months up to 5 years post study entry
Graft-versus-host disease incidence
6 months post transplant
Response Rates
6 and 12 months

Study Arms (1)

Non myeloblative allogeneic transplant

EXPERIMENTAL

Non myeloblative allogeneic hematopoietic cell transplantation after prior autologous transplantation

Biological: anti-thymocyte globulinBiological: G-CSFDrug: busulfanDrug: fludarabine phosphateDrug: methotrexateDrug: mycophenolate mofetilDrug: tacrolimusProcedure: allogeneic cell transplantationDrug: allopurinol

Interventions

anti-thymocyte globulinBIOLOGICAL

2.5mg/kg/day IV infusion over 6 hrs x 4 doses Days -4 to -1 (for MUD and 9/10 related donor transplants only)