Clinical trial NCT00683046: T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies
Official title: T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myelogenous Leukemia
Lymphoid Leukemia
Chronic Myelogenous Leukemia
Malignant Lymphoma
Hodgkin's Disease
Chronic Lymphocytic Leukemia
Myeloproliferative Disorder
Anemia, Aplastic
Myelodysplastic Syndromes
Keywords: 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.
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2008-05-23
Enrollment: 204
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objectives:

1. 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.
2. 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.
3. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Median Disease-free Survival
timeFrame: 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 outcomes:
measure: Median Overall Survival
timeFrame: 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
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Andrew Artz, MD
role: PRINCIPAL_INVESTIGATOR
References: