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Phase I/II Study of Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancy, Using MHC Identical or Near Identical Donors and Sub-Myeloablative Conditioning With CAMPATH 1H (DIMSUM)


Phase 1/Phase 2
N/A
70 Years
Not Enrolling
Both
Myelodysplastic Disorders, Leukemia, Multiple Myeloma, Plasma Cell Dyscrasia, Lymphoproliferative Disorders

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Trial Information

Phase I/II Study of Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancy, Using MHC Identical or Near Identical Donors and Sub-Myeloablative Conditioning With CAMPATH 1H (DIMSUM)


This is a two arm study in which outcomes will be assessed independently in recipients of
HLA matched sibling transplants and recipients of unrelated or mismatched family donor
transplants, although both groups will receive identical treatments.

The following will be given to the patient after admission:

Day - 6: Total body irradiation

Day - 5 to - 2: Fludarabine and Campath 1H

Day - 1: Day of rest

Day 0: Stem cell transplant (infusion)

Inclusion Criteria


Inclusion criteria

1. Diagnosis of myelodysplastic disorders, Acute Myelogenous Leukemia, Acute
Lymphoblastic Leukemia, Multiple Myeloma, Plasma Cell Dyscrasia, Lymphoproliferative
disorders (Non-Hodgkin Lymphoma, Hairy Cell Leukemia, Chronic Lymphocytic Leukemia
and Hodgkins Disease) or Renal Cell Carcinoma.

2. Conditions that increase treatment related mortality (need one or more to be
eligible):

1. Greater to or equal to 50 years of age.

2. EF of less than 45%

3. DLCO less than 50% of FEV1 50-75% of predicted value.

4. Diabetes Mellitus

5. Renal Insufficiency (but creatine clearance not less than 25ml/min).

6. Prior recent history of systemic fungal infection.

7. 3rd or greater remission of AML or ALL

8. More than 1 year of diagnosis (CML or Myeloma patients)

9. Multiple types of treatment regimens. (equal to or more than 3)

10. Prior autologous or allogeneic stem cell transplantation.

11. Significant grade III or IV neurologic or hepatic toxicity from previous
treatment.

12. No matched sibling donor.

3. Available healthy donor without any contraindications for donation. 5/6 or 6/6
related donor. 5/6 or 6/6 unrelated donor (molecular typing for DRB1)

4. Patient and/or responsible person able to understand consent.

5. Age between birth and 70 years.

6. For women of childbearing potential, negative pregnancy test.

Exclusion criteria

1. Patient is pregnant, lactating or unwilling to use contraceptives

2. HIV positive patient

3. Uncontrolled intercurrent infection

4. Refractory AML, or ALL

5. Untreated Blast Crisis for CML

6. Uncontrolled High-grade lymphoproliferative disease/lymphoma.

7. Unstable angina and uncompensated congestive heart failure (Zubrod of 3 or greater)

8. Severe chronic pulmonary disease requiring oxygen (Zubrod of 3 or greater)

9. Hemodialysis dependent

10. Active Hepatitis or cirrhosis with total bilirubin, SGOT, and SGPT greater than 3 x
normal.

11. Unstable Cerebral vascular disease and recent hemorrhagic stroke (less than 6 months)

12. Active CNS disease from hematological disorder.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

George Carrum, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

H8714

NCT ID:

NCT00048412

Start Date:

June 2000

Completion Date:

Related Keywords:

  • Myelodysplastic Disorders
  • Leukemia
  • Multiple Myeloma
  • Plasma Cell Dyscrasia
  • Lymphoproliferative Disorders
  • Leukemia
  • Lymphoproliferative Disorders
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Paraproteinemias

Name

Location

Texas Children's HospitalHouston, Texas  
The Methodist HospitalHouston, Texas  77030