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Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Hematologic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004114
Recruitment Status : Withdrawn (Study never opened)
First Posted : February 16, 2004
Last Update Posted : July 31, 2020
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells.

PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating patients who have advanced hematologic cancer.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Myelodysplastic Syndromes Biological: filgrastim Drug: cyclophosphamide Drug: cytarabine Drug: fludarabine phosphate Procedure: peripheral blood stem cell transplantation Phase 1

Detailed Description:

OBJECTIVES: I. Determine the feasibility of allogeneic engraftment after unrelated matched allogeneic peripheral blood stem cell transplantation preceded by a nonmyeloablative, fludarabine based conditioning regimen in patients with advanced hematologic malignancies. II. Determine the toxicities of this regimen, especially graft versus host disease, in these patients.

OUTLINE: Patients receive fludarabine IV over 30-60 minutes on days -7 to -4, cyclophosphamide IV over 30 minutes on days -7 to -5, and cytarabine IV over 2 hours on days -4 and -3. Allogeneic peripheral blood stem cells are infused on day 0. Filgrastim (G-CSF) is administered IV over 1 hour or subcutaneously beginning on day 1 and continuing until blood counts recover. Patients are followed weekly until day 60 and then monthly for 10 months.

PROJECTED ACCRUAL: A total of 6 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Primary Purpose: Treatment
Official Title: Non-Myeloablative Chemotherapy Followed by Unrelated Allogeneic Stem Cell Transplantation in Patients With Advanced Hematologic Malignancies: A Pilot Study

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically proven advanced hematologic malignancy unsuitable for standard allogeneic bone marrow transplantation One of the following types: Refractory or relapsed acute myelogenous or lymphocytic leukemia Over 55 years Chronic myelogenous leukemia and failed interferon treatment Over 55 years Lymphoma, chronic lymphocytic leukemia, Hodgkin's disease, or multiple myeloma: Refractory OR More than 2 relapses OR Relapse after autologous peripheral blood stem cell transplantation Myelodysplastic syndrome other than refractory anemia Severe aplastic anemia Under 55 years and either organ dysfunction or not eligible for standard allogeneic bone marrow transplant due to one or more of the following: Chronic hepatitis LVEF less than 50% Karnofsky less than 70% Unrelated matched donor available

PATIENT CHARACTERISTICS: Age: See Disease Characteristics Adult Performance status: See Disease Characteristics Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: See Disease Characteristics SGOT/SGPT no greater than 4 times upper limit of normal Renal: Creatinine no greater than 2 mg/dL Cardiovascular: See Disease Characteristics Pulmonary: DLCO at least 50% predicted Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004114

Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
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Study Chair: Christos E. Emmanouilides, MD Jonsson Comprehensive Cancer Center
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Responsible Party: Jonsson Comprehensive Cancer Center Identifier: NCT00004114    
Other Study ID Numbers: CDR0000067340
First Posted: February 16, 2004    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2012
Keywords provided by Jonsson Comprehensive Cancer Center:
recurrent adult Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
chronic myelomonocytic leukemia
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
recurrent adult T-cell leukemia/lymphoma
previously treated myelodysplastic syndromes
AIDS-related peripheral/systemic lymphoma
recurrent mantle cell lymphoma
anaplastic large cell lymphoma
refractory cytopenia with multilineage dysplasia
recurrent mycosis fungoides/Sezary syndrome
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
Additional relevant MeSH terms:
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Myelodysplastic Syndromes
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Fludarabine phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic