Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders

NCT00636909 | Completed Phase 2 DMC

• 2 other identifiers: 2001P002293W-99-0234-FB
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to provide allogeneic stem cell transplantation to patients who have not traditionally undergone this procedure because of it high incidence of treatment related side effects. We hope to decrease these side effects by decreasing the chemotherapy dose prior to transplant (non-myeloablative, smaller dose of chemotherapy given so bone marrow is not completely eliminated) and by using donated stem cells to treat cancer of the blood.

Conditions

AML; ALL; CML Chronic Phase, Accelerated Phase, or Blast Crisis; CLL; MDS; RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA; APLASTIC ANEMIA; MULTIPLE MYELOMA; MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET)

Keywords

AML; ALL; CML; CLL; MDS; NHL; HODGKIN'S LYMPHOMA; APLASTIC ANEMIA; MULTIPLE MYELOMA; MYELOPROLIFERATIVE DISORDER; ALLOGENEIC; STEM CELL TRANSPLANT; HEMATOLOGIC DISORDERS; CYCLOPHOSPHAMIDE; FLUDARABINE; CYCLOSPORINE; METHOTREXATE; G-CSF; GVHD; ENGRAFTMENT; CHIMERISM

Outcome Measures

Primary Outcomes (3)

• durable engraftment

  100 days

• hematopoeitic reconstitution

  3 years

• evaluate the patterns of post-transplant chimerism among lymphoid and antigen presenting cells

  3 years

Secondary Outcomes (2)

• disease free survival and overall survival

  3 years

• incidence of treatment related toxicity and acute and chronic graft versus host disease

  100 days

Study Arms (1)

1

EXPERIMENTAL

Study treatment arm with G-CSF

Drug: Cyclophosphamide; Drug: fludarabine; Drug: cyclosporine; Drug: methotrexate; Biological: G-CSF

Interventions

Cyclophosphamide DRUG

preparative cytoreduction

1

fludarabine DRUG

preparative cytoreduction

1

cyclosporine DRUG

immunosuppressive therapy

1

methotrexate DRUG

immunosuppressive therapy

1

G-CSF BIOLOGICAL

foster engraftment

1

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• AML, ALL,CML Chronic Phase, Accelerated Phase, or Blast Crisis, CLL, MDS, RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA, Aplastic Anemia, Multiple Myeloma, MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET
• Age less than 65 years
• Patients must have a healthy family member who is HLA-identical to the recipient or has 1 antigen mismatch and who is willing to receive a course of G-CSF and undergo 2-4 daily leukaphereses
• Each patient must sign an informed consent and be willing to participate as a research subject after having been advised of the nature and risk of the study prior to entering protocol
• Absence of hematologic or marrow function related diseases that interferes with the collection of sufficient numbers of normal progenitor cells
• Absence of any medical condition that would pose a serious health risk by undergoing peripheral blood stem cell harvest
• Negative HIV, HTLV-1, Hepatitis B surface antigen and Hepatitis C
• The donor must be blood relation. A prospective related donor must be at least genotypically HLA-A, B, DR identical to the patient, but can differ for 1 HLA-locus.

You may not qualify if:

• Active CNS involvement
• Females who are pregnant or breast feeding
• ECOG performance status \> 1. Karnofsky performance status \< 80%
• LVEF \< 40%
• Active viral, bacterial, or fungal infection
• Patients seropositive for HIV; HTLV -1
• Patients not providing informed consent
• Patients with known hypersensitivity to E. Coli derived product
• A positive HIv infection or HTLV - 1 test or evidence of active/persistent viral hepatitis infection. Presence of any medical condition that would pose a serious health risk by undergoing peripheral blood stem cell harvest. Donors with known hypersensitivity to E. Coli derived products.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Amgen: collaborator

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase; Blast Crisis; Anemia, Aplastic; Multiple Myeloma; Myeloproliferative Disorders; Hodgkin Disease; Hematologic Diseases

Interventions

Cyclophosphamide; fludarabine; Cyclosporine; Methotrexate; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Anemia; Bone Marrow Failure Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphoma; Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Proteins; Biological Factors

Study Officials

• David F McDermott, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

• David E Avigan, MD

  Beth Israel Deaconess Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 10, 2008
• First Posted: March 17, 2008
• Study Start: July 1, 1999
• Primary Completion: March 1, 2006
• Last Updated: April 6, 2017

Record last verified: 2017-04