Combination Chemotherapy Followed by Donor Bone Marrow Transplant or Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer or Genetic Disorders - Full Text View

Sponsors and Collaborators:	Herbert Irving Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00008307

Purpose

RATIONALE: Giving chemotherapy drugs, such as fludarabine and melphalan, before a donor bone marrow transplant or peripheral blood stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells and helps stop the growth of cancer or abnormal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy followed by donor bone marrow transplant or peripheral stem cell transplant works in treating patients with hematologic cancer or genetic disorders.

Condition	Intervention	Phase
Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes	Biological: anti-thymocyte globulin Drug: cyclosporine Drug: fludarabine phosphate Drug: melphalan Drug: methylprednisolone Drug: mycophenolate mofetil Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Procedure: syngeneic bone marrow transplantation	Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Bone Marrow Transplantation Cancer Fungal Infections Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma

Drug Information available for: Fludarabine Cyclosporine Fludarabine monophosphate Cyclosporin Methylprednisolone Mycophenolate mofetil hydrochloride Mycophenolate Mofetil Melphalan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Non-Ablative Chemotherapeutic Conditioning Before Allogeneic Stem Cell Transplantation

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Hematopoietic recovery [ Designated as safety issue: No ]
Incidence of graft-versus-host disease [ Designated as safety issue: No ]

Secondary Outcome Measures:

Chemotherapeutic toxicity [ Designated as safety issue: Yes ]
Relapse and survival [ Designated as safety issue: No ]

Estimated Enrollment:	52
Study Start Date:	April 1998

Detailed Description:

OBJECTIVES:

Determine the hematopoietic recovery in patients with hematologic malignancies or genetic disorders treated with fludarabine and melphalan followed by allogeneic or syngeneic bone marrow or peripheral blood stem cell transplantation.
Determine the chemotherapeutic toxicity of this regimen in these patients.
Determine the relapse and survival of patients treated with this regimen.
Determine the incidence of graft-versus-host disease in patients treated with this regimen.

OUTLINE: Patients receive fludarabine IV on days -6 to -2 and melphalan IV on days -3 and -2. Patients with a non-HLA-identical family member may also receive anti-thymocyte globulin on days -4 to -1. Patients undergo allogeneic or syngeneic bone marrow or peripheral blood stem cell transplantation on day 0. Patients receive graft-vs-host disease prophylaxis comprising mycophenolate mofetil twice daily beginning on day -3, methylprednisolone beginning on day 5 and continuing over 8 weeks, and cyclosporine IV or orally beginning on day -3 and continuing until at least 6 months post-transplantation.

Patients are followed at 1, 3, and 6 months, and then at 1 year post-transplantation.

PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study within 5-6 years.

Eligibility

Ages Eligible for Study:	1 Year to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Clinically and/or histologically confirmed hematologic malignancy or genetic disorder
- Chronic myelogenous leukemia
  - Typical blood and marrow morphology
  - Presence of Philadelphia chromosome OR
  - Molecular evidence of bcr/abl rearrangement if Philadelphia chromosome-negative
- Acute myeloid leukemia, acute lymphocytic leukemia, myelodysplasia, or lymphoma
  - High risk of relapse or progressive disease
  - Typical clinical features and morphology in blood, marrow, lymph node, or other tissue by cytochemistry, immunophenotyping, and/or chromosomal abnormalities
- Multiple myeloma
  - Typical marrow morphology, radiographic findings, and paraprotein
- Aplastic anemia
  - Typical marrow and blood findings
- Genetic disorder including storage disease (e.g., adrenoleukodystrophy), hemoglobinopathies (e.g., thalassemia), or severe immunodeficiency
Unwilling to undergo conventional high-dose chemoradiotherapeutic conditioning prior to allogeneic stem cell transplantation OR
Presence of other medical disorder which precludes high-dose chemoradiotherapeutic conditioning (e.g., cardiac disease or infection)
Syngeneic twin, HLA-identical, or 1 or 2 HLA antigen-mismatched family member or unrelated donor

PATIENT CHARACTERISTICS:

Age:

1 to 80

Performance status:

Karnofsky 50-100%

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

No other serious medical or psychiatric illness that would preclude study compliance
Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

See Disease Characteristics

Chemotherapy:

See Disease Characteristics

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics

Surgery:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00008307

Locations

United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032

Sponsors and Collaborators

Herbert Irving Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

David G. Savage, MD

Herbert Irving Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068396, CPMC-IRB-8462, CPMC-IRB-CAMP-25, NCI-G00-1897
Study First Received:	January 6, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00008307 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent childhood acute lymphoblastic leukemia
recurrent adult Hodgkin lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

stage I childhood lymphoblastic lymphoma
stage II childhood lymphoblastic lymphoma
stage III childhood lymphoblastic lymphoma
stage IV childhood lymphoblastic lymphoma
recurrent childhood lymphoblastic lymphoma
recurrent childhood acute myeloid leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid leukemia

Study placed in the following topic categories:

Philadelphia Chromosome
Anti-Inflammatory Agents
Blast Crisis
Cyclosporine
Mantle Cell Lymphoma
Cyclosporins
Preleukemia
Hemorrhagic Disorders
Lymphoma, Large-Cell, Anaplastic
Neoplasm Metastasis
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hematologic Diseases
Blood Coagulation Disorders
Leukemia, Myeloid
Glucocorticoids

Leukemia, Myeloid, Accelerated Phase
Chronic Myelogenous Leukemia
Fludarabine
Lymphoma, Non-Hodgkin
Precancerous Conditions
Immunologic Factors
Blood Protein Disorders
Lymphoma, Follicular
Sezary Syndrome
Lymphoblastic Lymphoma
Lymphoma, B-Cell
Leukemia
Cutaneous T-cell Lymphoma
Lymphoma, T-Cell
Antifungal Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Cyclosporine
Molecular Mechanisms of Pharmacological Action
Methylprednisolone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Cyclosporins
Preleukemia
Hemorrhagic Disorders
Pathologic Processes
Therapeutic Uses

Mycophenolate mofetil
Cardiovascular Diseases
Dermatologic Agents
Methylprednisolone Hemisuccinate
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Glucocorticoids
Multiple Myeloma
Neoplasms
Fludarabine
Lymphoma, Non-Hodgkin
Antimetabolites
Precancerous Conditions

ClinicalTrials.gov processed this record on May 06, 2009