Chemotherapy Followed by Allogeneic Stem Cell Transplantation for Hematologic Malignancies

NCT00741455 | Completed Results DMC

• 1 other identifier: D0345
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine disease-free survival, overall survival, time to progression, regimen-related toxicity and/or treatment-related mortality in patients with hematologic malignancies treated with non-myeloablative chemotherapy followed by allogeneic stem cell transplant.

Conditions

Hematologic Malignancies

Keywords

Non-myeloablative transplant; Chronic Myelogenous Leukemia; Acute Myelogenous Leukemia; Acute Lymphoblastic Leukemia; Multiple Myeloma; Non-Hodgkin's Lymphoma; Myelodysplastic syndrome; Chronic Lymphocytic Leukemia; Hodgkin's Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Successful Bone Marrow Engraftment

  Rates of successful engraftment.

  Within 30 days of bone marrow transplant

Secondary Outcomes (5)

• Number of Participants Who Achieve Complete Donor Chimerism

  Post-transplant days +30, +60, +100, +180 and +365

• Number of Participants Who Experienced Graft-Versus-Host-Disease

  Post-transplant procedure through death

• Overall Survival Measured in Participants

  Up to 15 Years Post-Transplant

• Collection of Adverse Events

  Until the 6th Bone Marrow Transplant performed in subjects on study

• Assess Disease Response

  Post-transplant procedure through death

Study Arms (1)

Study Treatment

EXPERIMENTAL

Chemotherapy, stem cell transplantation, HLA-Matched related allogeneic stem cell transplantation, leukapheresis, G-CSF, peripheral blood stem cell transplant, fludarabine, cyclophosphamide, donor lymphocyte infusion, cyclosporine, methotrexate

Procedure: Stem Cell Transplant; Drug: G-CSF; Drug: Fludarabine; Drug: cyclophosphamide; Drug: Cyclosporine; Drug: Methotrexate

Interventions

Stem Cell Transplant PROCEDURE

Donor: Prior to mobilization, leukapheresis to collect CD3+ cells. The donor will then receive G-CSF (10 mcg/kg/day) with leukapheresis collection of peripheral blood stem cells on days 5, 6 and 7 as needed. Goal of leukapheresis will be \> 5 x 106 CD34+cells/kg of recipient. Patient: Peripheral Blood Stem Cell (PBSC) Transplant. Fludarabine 25mg/m2/d IV over 30 minutes on days -6 to -2, followed by cyclophosphamide 1g/m2/d IV on days -3 and -2. This will be followed by allogeneic stem cell infusion 48 hours later. Donor Lymphocyte Infusion (DLI) and Adjustment of Immunosuppression: Cyclosporine (CSA) and methotrexate (MTX) will be used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml.

Also known as: HLA-Matched Related Allogeneic Stem Cell Transplantation

Study Treatment

G-CSF DRUG

10 mcg/kg/day on days 5, 6, and 7

Study Treatment

Fludarabine DRUG

25 mg/m2/d IV over 30 minutes on days -6 to -2

Study Treatment

cyclophosphamide DRUG

1 g/m2/d IV on days -3 and -2

Study Treatment

Cyclosporine DRUG

used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml

Study Treatment

Methotrexate DRUG

used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml

Study Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-75 years
• Diseases
• Chronic myelogenous leukemia (CML)
• First chronic phase or later
• Accelerated phase
• Acute myelogenous or lymphoblastic leukemia (AML or ALL)
• Second or subsequent remission
• Patients who have failed an autologous PBSC transplant
• First remission with poor risk features, including, but not limited to: For AML- complex chromosome karyotype, abnormalities of chromosome 5 or 7, 12p-, 13+, 8+, t(9;22), t(11;23) For ALL- t(9;22), t(4;11), t(1;19), myeloid antigen coexpression
• Myelodysplastic syndrome (MDS)
• Multiple myeloma - high risk myeloma (poor responders, relapse after autologous PBSCT, chromosome 13 abnormalities)
• Hodgkin's disease
• Primary refractory disease
• Relapsed disease (first relapse or later)
• Patients who have failed an autologous PBSC transplant

You may not qualify if:

• Major organ dysfunction
• Pregnant or lactating female
• Active infection
• Psychological problems that preclude compliance and completion of the clinical trial
• Any other condition, that in the judgement of the investigator, affects participant safety or overall participation

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Multiple Myeloma; Lymphoma, Non-Hodgkin; Myelodysplastic Syndromes; Leukemia, Lymphocytic, Chronic, B-Cell; Hodgkin Disease

Interventions

Stem Cell Transplantation; Granulocyte Colony-Stimulating Factor; fludarabine; Cyclophosphamide; Cyclosporine; Methotrexate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Lymphoma; Leukemia, B-Cell

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Darcie Findley
• Organization: Dartmouth-Hitchcock Medical Center

darcie.l.findley@hitchcock.org

603-650-4595

Study Officials

• John M Hill, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

• Kenneth R Meehan, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Allogeneic Bone Marrow Transplant Program

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 26, 2008
• Study Start: June 1, 2004
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: November 23, 2020
• Results First Posted: November 23, 2020

Record last verified: 2020-10

Locations

US (1)