Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
27 participants
INTERVENTIONAL
2000-08-31
2014-09-30
Brief Summary
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Stem cells are created in the bone marrow. They grow into different types of blood cells that the patient needs, including red blood cells, white blood cells, and platelets. In a transplant, the patient's own stem cells are killed and then replaced by stem cells from the donor.
Usually, patients are given very strong doses of chemotherapy prior to receiving a stem cell transplant. However, because of the patient's condition, they have a high risk of experiencing life-threatening treatment-related side-effects. Recently, some doctors have begun to use chemotherapy that does not cause as many side-effects before patients receive a transplant.
This research study adds CAMPATH 1H to a low-dose chemotherapy regimen, followed by an allogeneic stem cell transplantation. We want to see whether adding CAMPATH 1H to the transplant medications helps in treating the disease. We also want to see whether there are fewer life-threatening side-effects from the treatment. CAMPATH 1H is a drug that is still being studied. CAMPATH 1H stays active in the body for a long time after patients receive it, which means it may work longer at preventing graft-versus-host-disease (GvHD) symptoms.
Detailed Description
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After admission to the hospital, patients will receive total body irradiation (very strong x-rays that kill cells in the bone marrow), Fludarabine and Campath 1H prior to the stem cell transplant (infusion of the donor's stem cells).
Starting 7 days after the transplant, the patient will be given G-CSF by subcutaneous injection, until a blood test shows that numbers of granulocytes (a type of white blood cell) in the blood are more than 1,000/uL. This is to help increase blood cell counts.
After transplantation, the patient will undergo several evaluations at different times. These are standard evaluations and tests performed 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 performed at regular intervals (every 3 to 6 months) for 2 years.
Depending on how well the donor 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Stem Cell Transplant
Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.
Campath 1H
Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.
Fludarabine
Day -5 to Day -2: Fludarabine 30 mg/m2.
Stem Cell Transplant
Day 0: Donor stem cells infused.
Total Body Irradiation (TBI)
Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.
FK506 (Tacrolimus) or Cyclosporine
Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD.
Interventions
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Campath 1H
Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.
Fludarabine
Day -5 to Day -2: Fludarabine 30 mg/m2.
Stem Cell Transplant
Day 0: Donor stem cells infused.
Total Body Irradiation (TBI)
Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.
FK506 (Tacrolimus) or Cyclosporine
Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD.
Eligibility Criteria
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Inclusion Criteria
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 from 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. This 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 greatest number of MHC loci. Matching will be determined by Class I and Class II DNA typing. The donor should be sufficiently healthy as to not be at increased risk from the stem cell 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 legal representative and/or legal guardian 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.
Exclusion Criteria
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 3X upper limit of normal.
10. Unstable cerebral vascular disease and recent hemorrhagic stroke (less than 6 months).
11. Active CNS disease from hematological disorder.
70 Years
ALL
No
Sponsors
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The Methodist Hospital Research Institute
OTHER
Baylor College of Medicine
OTHER
Responsible Party
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George Carrum
Principal Investigator
Principal Investigators
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George Carrum, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine; The Methodist Hospital
Locations
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Texas Children's Hospital
Houston, Texas, United States
The Methodist Hospital
Houston, Texas, United States
Countries
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Other Identifiers
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8713-HIMSUM
Identifier Type: -
Identifier Source: org_study_id