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A Pilot Study of Combined Chemotherapy and Donor Lymphocyte Infusion for Hematologic Malignancies in Relapse After Allogeneic Bone Marrow Transplantation


Phase 1
N/A
N/A
Open (Enrolling)
Both
Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes

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Trial Information

A Pilot Study of Combined Chemotherapy and Donor Lymphocyte Infusion for Hematologic Malignancies in Relapse After Allogeneic Bone Marrow Transplantation


OBJECTIVES: I. Determine the minimum amount of chemotherapy in combination with donor
lymphocyte infusion required to obtain a rate of 30-60% graft versus host disease in
patients with hematologic malignancies relapsed after allogeneic stem cell transplantation.

OUTLINE: This is a dose de-escalation study. Patients receive etoposide IV continuously on
days 1-3; cyclophosphamide IV on day 8; donor lymphocyte infusion IV on day 10; and
filgrastim (G-CSF) subcutaneously or IV beginning on day 10 and continuing until blood
counts recover. Cohorts of 3-6 patients receive six de-escalating levels of chemotherapy
until the minimum amount of chemotherapy in combination with donor lymphocyte infusion
required to obtain a rate of 30-60% graft versus host disease (GVHD) is determined. The
target dose level is defined as the level at which 2 of 6 patients develop GVHD, and the
next lower dose level has no more than 1 patient experiencing GVHD. Patients are followed
every 3 months for the first year, every 6 months for the second year, and yearly
thereafter.

PROJECTED ACCRUAL: A total of 18-21 patients will be accrued over 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed relapsed or refractory hematologic
malignancy Acute leukemia Myelodysplasia Non-Hodgkin's lymphoma Hodgkin's disease Multiple
myeloma Chronic lymphocytic leukemia Chronic myeloid leukemia Accelerated phase or blast
crisis Chronic phase with failed prior donor lymphocyte infusion No active acute or
extensive chronic graft versus host disease Prior allogeneic stem cell transplant (SCT)
required At least 60 days since prior SCT Nonmyeloablative SCT allowed

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy:
Greater than 4 weeks Hematopoietic: Not specified Hepatic: Not specified Renal: Not
specified Other: No severe psychiatric illness that may preclude informed consent Fertile
patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 7 days
since prior immunomodulatory medications (e.g., interferon or interleukin-2) Chemotherapy:
Not specified Endocrine therapy: At least 7 days since prior steroids Radiotherapy: Not
specified Surgery: Not specified Other: At least 7 days since prior immunosuppressives
(e.g., cyclosporine, tacrolimus, or mycophenolate mofetil) No concurrent immunosuppressive
medications for graft versus host disease

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Bijoyesh Mookerjee, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jefferson Medical College of Thomas Jefferson University

Authority:

United States: Federal Government

Study ID:

CDR0000067863

NCT ID:

NCT00005946

Start Date:

October 2000

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent adult Hodgkin lymphoma
  • refractory 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
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • 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
  • secondary myelodysplastic syndromes
  • 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
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201