Clinical trial · Interventional

Removal of T Cells to Prevent Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation

T-Cell Depletion for Graft-Versus-Host Disease (GVHD) Prevention in High Risk Matched and Mismatched Allogeneic Bone Marrow Transplantation

NCT00005641CI-TRIAL-00008653terminatedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): low study accrual

Summary

Brief summary (as posted)

RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Eliminating the T cells from the donor cells before transplanting them may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of T cell removal to prevent graft-versus-host disease in patients who are undergoing bone marrow transplantation from a donor.

Conditions

Conditions (5)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Chronic Myeloproliferative Disorders	Myeloproliferative Neoplasm	ALIAS	0.90
Graft Versus Host Disease	—	UNRESOLVED	—
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Multiple Myeloma and Plasma Cell Neoplasm	—	UNRESOLVED	—
Myelodysplastic Syndromes	Myelodysplastic Syndrome	ALIAS	0.90

Interventions

Interventions (10)

Intervention	Type	Mapped drug	Match
allogeneic bone marrow transplantation	Procedure	—	UNRESOLVED
anti-thymocyte globulin	Biological	—	UNRESOLVED
busulfan	Drug	Busulfan	ALIAS
cyclophosphamide	Drug	Cyclophosphamide	ALIAS
cyclosporine	Drug	—	UNRESOLVED
in vitro-treated bone marrow transplantation	Procedure	—	UNRESOLVED
leucovorin calcium	Drug	Leucovorin	ALIAS
methotrexate	Drug	Methotrexate	ALIAS

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 15 Years
Maximum age: 60 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS: Histologically confirmed malignancy Acute myeloid leukemia (AML) Complete remission 1 (CR1): high risk defined by poor cytogenetics (e.g., deletions, additions, or multiple abnormalities) Complete remission 2 (CR2) Induction failures Relapse: at least one reinduction attempt if at least 10% marrow blasts Acute lymphocytic leukemia CR1: high risk defined by overt CNS involvement or poor cytogenetics (e.g., additions, deletions, translocations, or multiple abnormalities) CR2 Induction failures Relapse as for AML Chronic myelogenous leukemia Chronic phase (CP) 1 Accelerated phase (AP)/CP2: blast phase patients require induction and achievement of a second chronic phase prior to transplantation Chronic lymphocytic leukemia Relapse: any stage and must have received no greater than 3 regimens since diagnosis Multiple myeloma Primary refractory disease at diagnosis Relapse (no greater than 2): sensitive disease Plasma cell leukemia Inability to achieve a complete remission or relapse after autologous transplantation (no greater than 40 years) Myelodysplasia All FAB subtypes Myeloproliferative disorders Poor response to medical therapy OR Cytogenetic abnormalities Severe aplastic anemia (SAA) (for unrelated and/or mismatched donors) Very SAA at diagnosis OR SAA: induction failures One antigen mismatch (recipient age 15 to 55) Related donors may be A, B, or DR mismatched Unrelated donors may be A or B mismatched (DRB1 match) Phenotypic (6 out of 6) match Recipient age 51 to 60 if related donor Recipient age 41 to 55 if unrelated donor

PATIENT CHARACTERISTICS: Age: 15 to 60 Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT/SGPT no greater than 3 times normal PT/PTT normal Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: LVEF at least 45% by MUGA scan or echocardiography Greater than 6 months since myocardial infarction No uncontrolled arrhythmias Pulmonary: FEV1 and DCLO at least 50% predicted Other: No psychosocial conditions that would preclude study No uncontrolled diabetes mellitus No uncontrolled thyroid disease No active serious infections HIV negative Not pregnant or nursing Negative pregnancy test

PRIOR CONCURRENT THERAPY: See Disease Characteristics

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Sep 1, 1997
Primary completion: Sep 1, 2000
Completion: Sep 1, 2000
First posted: Jun 8, 2004
Last update posted: Dec 11, 2012
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute OTHER
Collaborators: National Cancer Institute (NCI)
Keywords: recurrent childhood acute lymphoblastic leukemia, refractory multiple myeloma, stage 0 chronic lymphocytic leukemia, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, recurrent childhood acute myeloid leukemia, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, refractory chronic lymphocytic leukemia, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, adult acute myeloid leukemia in remission, adult acute lymphoblastic leukemia in remission, polycythemia vera, primary myelofibrosis, essential thrombocythemia, refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, graft versus host disease, refractory cytopenia with multilineage dysplasia, childhood myelodysplastic syndromes

Data updated 22 days agoSource updated Dec 11, 2012source: clinicaltrials

Brief summary (as posted)

Conditions (5)

Interventions (10)

Eligibility (as posted)

Publications (0)

Locations by country (1)