T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies

Study Overview
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Brief Summary
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Objectives: To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies. To evaluate the incidence and severity of acute and chronic GVHD after Campath 1H-based in vivo T-cell depletion, in patients with hematologic malignancies undergoing non-myelo-ablative stem cell transplantation. To evaluate engraftment and chimerism after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.

Official Title
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T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies

Conditions
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Acute Myelogenous Leukemia, Lymphoid Leukemia, Chronic Myelogenous Leukemia, Malignant Lymphoma, Hodgkin's Disease, Chronic Lymphocytic Leukemia, Myeloproliferative Disorder, Anemia, Aplastic, Myelodysplastic Syndromes

Intervention / Treatment
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* Drug: Fludarabine
* Drug: Melphalan
* Drug: Stem cells
* Drug: Campath


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Zubrod performance status 2 (See Appendix B). Life expectancy is not severely limited by concomitant illness. Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTS will be evaluated by cardiology or pulmonary prior to enrollment on this protocol. Serum creatinine <1.5 mg/dL or Creatinine Clearance >50 ml/min . Serum bilirubin 2.0 mg/dl, SGPT <3 x upper limit of normal No evidence of chronic active hepatitis or cirrhosis. HIV-negative Patient is not pregnant Patient or guardian able to sign informed consent. Exclusion Criteria: N/A

Ages Eligible for Study
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Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug Intervention<br> | Drug: Fludarabine<br>* Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3,.<br>Drug: Melphalan<br>* Melphalan 140 mg/m2 IV on day -2.<br>Drug: Stem cells<br>* Stem cell infusion on day 0.<br>Drug: Campath<br>* Campath, 20 mg IV on day -7, 6, -5, -4, and -3.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Disease-free Survival | All patients were administered the following drugs; Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 Melphalan 140mg/m2 IV on day -2 Stem cell infusion on day 0 Campath 20mg IV on day -7,-6,-5,-4, and -3 | Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Overall Survival | All patients were administered the following drugs; Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3 Melphalan 140mg/m2 IV on day -2 Stem cell infusion on day 0 Campath 20mg IV on day -7,-6,-5,-4, and -3 | Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapsed or refractory acute myelogenous or lymphoid leukemia., Acute myeloid or lymphocytic leukemia in first remission at high-risk for recurrence.Chronic myelogenous leukemia in accelerated phase or blast-crisis., Chronic myelogenous leukemia in chronic phase, Chronic myelogenous leukemia in accelerated phase or blast-crisis, Recurrent or refractory malignant lymphoma or Hodgkin's disease., Chronic lymphocytic leukemia, relapsed or with poor prognostic features., Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor prognostic features., Severe aplastic anemia after failure of immunosuppressive therapy., Myelodysplastic syndromes (including PNH), Multiple myeloma at high risk for disease recurrence.