Clinical trial NCT00827099
Conditions: Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes
Keywords: accelerated phase cml adult ALL in remission adult AML in remission adult AML with 11q23 (MLL) abnormalities adult AML with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) blastic phase chronic myelogenous leukemia chronic myelomonocytic leukemia chronic phase chronic myelogenous leukemia prolymphocytic leukemia recurrent adult T-cell leukemia/lymphoma relapsing chronic myelogenous leukemia secondary acute myeloid leukemia refractory chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent adult Hodgkin lymphoma anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma cutaneous B-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent mycosis fungoides/Sezary syndrome adult grade III lymphomatoid granulomatosis adult nasal type extranodal NK/T-cell lymphoma Waldenstrom macroglobulinemia extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult grade III lymphomatoid granulomatosis recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma chronic idiopathic myelofibrosis stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes
Sponsor: Northside Hospital, Inc.
Start date: 2006-06-01; Completion date: 2009-11-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Giving low doses of chemotherapy before a donor umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving umbilical cord blood transplant together with fludarabine, melphalan, and antithymocyte globulin works in treating patients with hematologic cancer.

Detailed description:
OBJECTIVES:

Primary

* To evaluate the 100-day transplant-related (non-relapse) mortality in patients with hematologic malignancies undergoing reduced-intensity conditioning comprising fludarabine phosphate, melphalan, and anti-thymocyte globulin followed by sequential umbilical cord blood transplantation (UCBT) from 2 partially-matched unrelated donors.

Secondary

* To evaluate the 12-month transplant-related (non-relapse) mortality.
* To evaluate the days to neutrophil engraftment (ANC \> 500/mm³).
* To evaluate the days to platelet engraftment (platelet count \> 20,000/mm³ \[unsupported\]).
* To evaluate the risk of acute and chronic graft-vs-host disease.
* To evaluate percent donor chimerism contribution of each cord unit.
* To evaluate relapse rate.
* To evaluate disease-free and overall survival.
* To evaluate transfusion support needed for UCBT recipients.

OUTLINE:

* Conditioning regimen: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, melphalan IV over 30-60 minutes on day -2, and anti-thymocyte globulin IV over 4-6 hours on days -4 to -2.
* Transplantation: Patients undergo two sequential umbilical cord blood transplantations on day 0.
* Graft-vs-host disease (GVHD) prophylaxis: Patients receive tacrolimus IV continuously and then orally twice daily beginning on day -1 and continuing until day 60, followed by a taper until day 180 in the absence of GVHD. Patients also receive mycophenolate mofetil IV or orally twice daily beginning on day 0 and continuing until day 30, followed by a taper until day 60 in the absence of GVHD.

After completion of study treatment, patients are followed periodically.

Interventions: intervention 1: anti-thymocyte globulin intervention 2: fludarabine phosphate intervention 3: Melphalan intervention 4: mycophenolate mofetil intervention 5: tacrolimus intervention 6: umbilical cord blood transplantation
Intervention descriptions: intervention 1: anti-thymocyte globulin intervention 2: fludarabine phosphate intervention 3: melphalan intervention 4: mycophenolate mofetil intervention 5: tacrolimus intervention 6: umbilical cord blood transplantation

Protocol documents: