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Phase I/II Study of Allogeneic Stem Cell Transplantation for Patients With Hematologic Diseases Using Haploidentical Family Donors and Sub-Myeloablative Conditioning With Campath 1H

Phase 1/Phase 2
70 Years
Open (Enrolling)
Hematologic Malignancies

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Trial Information

Phase I/II Study of Allogeneic Stem Cell Transplantation for Patients With Hematologic Diseases Using Haploidentical Family Donors and Sub-Myeloablative Conditioning With Campath 1H

Before treatment begins, stem cells will be collected from the donor's blood or bone marrow.
The stem cells will be collected and frozen before we start to give the patient

After admission to the hospital, patients will receive total body irradiation (very strong
type of x-rays that kill cells in the bone marrow), Fludarabine and Campath 1H prior to the
Stem cell transplant (infusion of the donors stem cells).

Starting 7 days after the transplant, the patient will be given G-CSF by subcutaneous
injection until a blood test shows that granulocytes (a type of white blood cell) are more
than 1000/ul. This is to help increase blood counts.

After transplantation, the patient will have several evaluations at different times. These
are standard evaluations and tests done for any patient who has received a stem cell
transplant as part of routine clinical monitoring:

We will also be looking at the patient's immune function (how the body protects itself to
prevent and fight infections and diseases). To do this blood tests will be done at regular
intervals (every 3 to 6 months) for 2 years.

Depending on how well the donors stem cells work in the body after the transplant, the
patient may receive one or more Donor Leukocyte Infusions (DLI). This is when leukocytes (a
type of white blood cell) collected from the same donor that provided the stem cells are
given to the patient through a central line into a vein.

Inclusion Criteria


1. Diagnosis of myelodysplastic disorders, Fanconi's anemia, Acute Myelogenous Leukemia
(including secondary), Acute Lymphoblastic Leukemia, Multiple Myeloma, Plasma Cell
Dyscrasia, Lymphoproliferative disorders (Non-Hodgkin Lymphoma, Hairy Cell Leukemia,
or Chronic Lymphocytic Leukemia and Hodgkin's Disease). Diagnosis of Myelodysplastic
disorders which is not good risk by IPSS, Fanconi's anemia, Acute Myelogenous
Leukemia (1st or subsequent relapse or 2nd or subsequent CR or refractory disease),
Acute Lymphoblastic Leukemia in 2nd or subsequent remission or relapse or refractory
disease, or Philadelphia chromosome positive, Chronic Myelogenous Leukemia (failed
STI and interferon), Multiple Myeloma (stage II or III), Lymphoma, Chronic
Lymphocytic Leukemia (primary refractory or recurrent disease), Hodgkin's Disease
(after relapse), Hemophagocytic Lymphohistiocytosis (failed chemotherapy and/or
anti-viral therapy), or bone marrow failure such as Aplastic Anemia and Paroxysmal
nocturnal hemoglobinuria, PNH (failed prior therapies).

2. Conditions that increase treatment related mortality: (need one or more to be
eligible): Age > / = 50 years; EF of less than 45%; DLCO less than 50% or FEVI 50-75%
of predicted value; Diabetes Mellitus; Renal Insufficiency (but creatinine clearance
not less than 25 ml/min); Prior recent history of systemic fungal infection; 3rd or
greater remission of AML or ALL; Significant grade III or IV neurologic or hepatic
toxicity from previous treatment; More than 1 year of diagnosis (CML or Myeloma
patients ONLY); Multiple types of treatment regimens (equal to or more than 3);
significant Grade III or IV neurologic or hepatic toxicity from previous treatment;
Prior autologous or allogeneic stem cell transplantation.

3. Haploidentical family member donor. The protocol is open to patients who lack a 5/6
or 6/6 HLA antigen matched donor. Due to the increased risk of GVHD, patients with
Fanconi anemia and a 5/6 HLA match will also be eligible.

For this protocol, the "best" donor will be defined as a first-degree haploidentical
family member who matches at the most MHC loci. Matching will be determined by class
I and class II DNA typing. The donor should be sufficiently healthy not to be at
increased risk from the mobilization procedure. Should more than one "equally" MHC
incompatible donor be identified, other selection criteria will include: age and size
of donor, CMV status and sex. The Principal Investigator will make final decisions.

4. Available healthy donor without any contraindications for donation.

5. Patient and/or responsible person able to understand and sign consent.

6. Age between birth and 70 years.

7. Women of child bearing potential must have a negative pregnancy test.


1. Pregnant, lactating or unwilling to use contraception.

2. HIV positive patient.

3. Uncontrolled intercurrent infection.

4. Untreated Blast Crisis for CML.

5. Uncontrolled High-grade lymphoproliferative disease / lymphoma.

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

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

8. Hemodialysis dependent.

9. Active hepatitis or cirrhosis with total bilirubin, SGOT, and SGPT greater than 3 x
upper limit of normal.

10. Unstable Cerebral vascular disease and recent hemorrhagic stroke (less than 6

11. Active CNS disease from hematological disorder.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess the treatment related mortality

Outcome Time Frame:

100 days

Safety Issue:


Principal Investigator

George Carrum, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine; The Methodist Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

August 2000

Completion Date:

December 2015

Related Keywords:

  • Hematologic Malignancies
  • Campath
  • Neoplasms
  • Hematologic Diseases
  • Hematologic Neoplasms



Texas Children's Hospital Houston, Texas  
The Methodist Hospital Houston, Texas  77030