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Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

Primary Purpose

Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
anti-thymocyte globulin
graft-versus-tumor induction therapy
cyclophosphamide
melphalan
peripheral blood stem cell transplantation
radiation therapy
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring recurrent childhood acute lymphoblastic leukemia, recurrent adult Hodgkin lymphoma, refractory multiple myeloma, Waldenstrom macroglobulinemia, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, recurrent childhood lymphoblastic lymphoma, recurrent childhood acute myeloid leukemia, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, refractory chronic lymphocytic leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, adult acute myeloid leukemia in remission, adult acute lymphoblastic leukemia in remission, childhood acute myeloid leukemia in remission, childhood acute lymphoblastic leukemia in remission, adult acute erythroid leukemia (M6), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute promyelocytic leukemia (M3), adult acute eosinophilic leukemia, adult acute basophilic leukemia, adult acute megakaryoblastic leukemia (M7), childhood acute myeloblastic leukemia without maturation (M1), childhood acute myeloblastic leukemia with maturation (M2), childhood acute promyelocytic leukemia (M3), childhood acute erythroleukemia (M6), childhood acute eosinophilic leukemia, childhood acute basophilic leukemia, childhood acute megakaryocytic leukemia (M7), recurrent/refractory childhood Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, previously treated myelodysplastic syndromes, adult acute minimally differentiated myeloid leukemia (M0), childhood acute minimally differentiated myeloid leukemia (M0), recurrent childhood small noncleaved cell lymphoma, recurrent childhood large cell lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, childhood myelodysplastic syndromes

Eligibility Criteria

undefined - 120 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Patients with HLA identical family donors and any one of the following conditions documented by marrow aspiration and biopsy: -Acute leukemia refractory to induction treatment or after 1 or more relapses -Acute myeloid leukemia with t(9;22), -5/5q-, -7/7q-, and 11q23 involvement in first remission (not M4 or M5) -Acute lymphocytic leukemia with t(9;22) or t(4;11) in first remission -Myelodysplastic syndrome with greater than 5% bone marrow blasts -Chronic myeloid leukemia in accelerated phase or nonlymphoid blast crisis -Myeloma, chronic lymphocytic leukemia, non-Hodgkin's lymphoma, or Hodgkin's disease refractory to 2 lines of standard treatment or progression on standard treatment No evidence of active extramedullary disease PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70-100% Life expectancy: Greater than 8 weeks Hematopoietic: Not specified Hepatic: Bilirubin less than 2.0 mg/dL SGOT no greater than 4 times upper limit of normal and not increasing for 2-4 weeks prior to transplant Renal: Creatinine less than 2 times normal and not increasing for 2-4 weeks prior to transplant OR Creatinine clearance greater than 60 mL/min Cardiovascular: LVEF greater than 50% by MUGA Pulmonary: DLCO greater than 50% Other: Not HIV positive Not pregnant or nursing Fertile patients must use effective contraceptive PRIOR CONCURRENT THERAPY: See Disease Characteristics

Sites / Locations

  • Marlene & Stewart Greenebaum Cancer Center, University of Maryland

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
October 15, 2019
Sponsor
University of Maryland, Baltimore
Collaborators
University of Maryland Greenebaum Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00003396
Brief Title
Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Official Title
Evaluation of Allogeneic Peripheral Blood Stem Cell Transplants From a Related Donor Without Graft-Versus-Host Prophylaxis in Patients With High Risk of Relapse
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
December 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Maryland, Baltimore
Collaborators
University of Maryland Greenebaum Cancer Center

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation from related donors to prevent graft-versus-host disease in treating patients with hematologic cancer.
Detailed Description
OBJECTIVES: I. Evaluate the use of donor peripheral blood stem cells without graft-versus-host disease prophylaxis to maximize the probability of graft-versus-tumor effect in patients with hematologic malignancies refractory to standard chemotherapy and unlikely to be cured with high dose chemotherapy and radiotherapy. OUTLINE: Prior to peripheral blood stem cell transplant, patients undergo preparative cytoreduction. Patients receive total body irradiation (TBI) beginning on day -5. Radiotherapy is administered in 9 doses over 3 days (3 doses per day for 3 days). Male patients with acute lymphocytic leukemia receive an additional dose of radiation to the testicles. Patients who are ineligible for TBI due to prior radiotherapy receive 2 doses of melphalan IV on day -3. All patients receive cyclophosphamide IV over 1 hour on days -2 and -1. Anti-thymocyte globulin is also administered IV over 6 hours on days -2 and -1. Approximately 24-36 hours after the last dose of cyclophosphamide, peripheral blood stem cells obtained from the HLA matched related donor are infused into the patient. Patients do not receive graft-versus-host disease prophylaxis after transplant; however, all other forms of supportive care are provided. Patients are followed for 1 year. PROJECTED ACCRUAL: A maximum of 42 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
Keywords
recurrent childhood acute lymphoblastic leukemia, recurrent adult Hodgkin lymphoma, refractory multiple myeloma, Waldenstrom macroglobulinemia, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, recurrent childhood lymphoblastic lymphoma, recurrent childhood acute myeloid leukemia, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, refractory chronic lymphocytic leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, adult acute myeloid leukemia in remission, adult acute lymphoblastic leukemia in remission, childhood acute myeloid leukemia in remission, childhood acute lymphoblastic leukemia in remission, adult acute erythroid leukemia (M6), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute promyelocytic leukemia (M3), adult acute eosinophilic leukemia, adult acute basophilic leukemia, adult acute megakaryoblastic leukemia (M7), childhood acute myeloblastic leukemia without maturation (M1), childhood acute myeloblastic leukemia with maturation (M2), childhood acute promyelocytic leukemia (M3), childhood acute erythroleukemia (M6), childhood acute eosinophilic leukemia, childhood acute basophilic leukemia, childhood acute megakaryocytic leukemia (M7), recurrent/refractory childhood Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, previously treated myelodysplastic syndromes, adult acute minimally differentiated myeloid leukemia (M0), childhood acute minimally differentiated myeloid leukemia (M0), recurrent childhood small noncleaved cell lymphoma, recurrent childhood large cell lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, childhood myelodysplastic syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
anti-thymocyte globulin
Intervention Type
Biological
Intervention Name(s)
graft-versus-tumor induction therapy
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
melphalan
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Patients with HLA identical family donors and any one of the following conditions documented by marrow aspiration and biopsy: -Acute leukemia refractory to induction treatment or after 1 or more relapses -Acute myeloid leukemia with t(9;22), -5/5q-, -7/7q-, and 11q23 involvement in first remission (not M4 or M5) -Acute lymphocytic leukemia with t(9;22) or t(4;11) in first remission -Myelodysplastic syndrome with greater than 5% bone marrow blasts -Chronic myeloid leukemia in accelerated phase or nonlymphoid blast crisis -Myeloma, chronic lymphocytic leukemia, non-Hodgkin's lymphoma, or Hodgkin's disease refractory to 2 lines of standard treatment or progression on standard treatment No evidence of active extramedullary disease PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70-100% Life expectancy: Greater than 8 weeks Hematopoietic: Not specified Hepatic: Bilirubin less than 2.0 mg/dL SGOT no greater than 4 times upper limit of normal and not increasing for 2-4 weeks prior to transplant Renal: Creatinine less than 2 times normal and not increasing for 2-4 weeks prior to transplant OR Creatinine clearance greater than 60 mL/min Cardiovascular: LVEF greater than 50% by MUGA Pulmonary: DLCO greater than 50% Other: Not HIV positive Not pregnant or nursing Fertile patients must use effective contraceptive PRIOR CONCURRENT THERAPY: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry R. Meisenberg, MD
Organizational Affiliation
University of Maryland Greenebaum Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

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Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

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