Busulfan/Clofarabine + Allogeneic Stem Cell Transplantation
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/23/2017 |
| Start Date: | July 2012 |
| End Date: | August 2016 |
Phase II Study of Reduced Intensity Conditioning With Busulfan/Clofarabine Followed by Allogeneic Stem Cell Transplantation
This research is a phase II clinical trial. Phase II clinical trials test the effectiveness
of an investigational intervention to learn whether it works in treating a specific cancer.
"Investigational" means that the study intervention is still being studied and that research
doctors are trying to find out more about it. It also means that the FDA has not yet
approved this study intervention for your type of cancer.
All participants on this study are treated in an identical manner. The investigators are
doing this study because there continues to be a significant risk of relapse of disease
after reduced intensity transplantation. In studies which have compared transplants using
high-doses of chemotherapy and/or radiation versus reduced intensity transplants, patients
undergoing reduced intensity transplants appear to have higher rates of relapse, but lower
rates of toxicity and complication. This study attempts to utilize clofarabine, a newer
chemotherapy agent shown to be quite active in AML, ALL, and MDS, to increase the anti-tumor
effects of the conditioning regimen without accumulating unacceptable toxicity.
The reduced intensity allogeneic stem cell transplantation procedure involves giving you
chemotherapy in relatively less intense doses to suppress your immune system. This is
followed by an infusion of healthy blood stem cells from a matched related donor or a
matched unrelated volunteer donor. It is hoped that these donor cells can eventually then
attack any cancer cells which remain.
In this research study, the investigators are looking to see how well this new combination
of busulfan and clofarabine works in reduced intensity allogeneic stem cell transplantation.
By "works" the investigators mean to analyze safety, ability of donor cells to engraft (take
hold), as well as measures of complications including toxicity, infections, graft-vs-host
disease (GVHD), and relapse.
of an investigational intervention to learn whether it works in treating a specific cancer.
"Investigational" means that the study intervention is still being studied and that research
doctors are trying to find out more about it. It also means that the FDA has not yet
approved this study intervention for your type of cancer.
All participants on this study are treated in an identical manner. The investigators are
doing this study because there continues to be a significant risk of relapse of disease
after reduced intensity transplantation. In studies which have compared transplants using
high-doses of chemotherapy and/or radiation versus reduced intensity transplants, patients
undergoing reduced intensity transplants appear to have higher rates of relapse, but lower
rates of toxicity and complication. This study attempts to utilize clofarabine, a newer
chemotherapy agent shown to be quite active in AML, ALL, and MDS, to increase the anti-tumor
effects of the conditioning regimen without accumulating unacceptable toxicity.
The reduced intensity allogeneic stem cell transplantation procedure involves giving you
chemotherapy in relatively less intense doses to suppress your immune system. This is
followed by an infusion of healthy blood stem cells from a matched related donor or a
matched unrelated volunteer donor. It is hoped that these donor cells can eventually then
attack any cancer cells which remain.
In this research study, the investigators are looking to see how well this new combination
of busulfan and clofarabine works in reduced intensity allogeneic stem cell transplantation.
By "works" the investigators mean to analyze safety, ability of donor cells to engraft (take
hold), as well as measures of complications including toxicity, infections, graft-vs-host
disease (GVHD), and relapse.
You will start the conditioning regimen, which is also called the preparative regimen.
Conditioning is done to kill more cancer cells which may remain as well as prepare your body
for transplant. You will receive the conditioning drugs into a vein. The conditioning
regimen consists of the following drugs: Busulfan and Clofarabine.
While you are in the hospital you will have regular physical exams and you will be asked
specific questions about any problems that you might be having. You will also have blood
tests every day to look at how your bone marrow is recovering, to give possible
transfusional support, and how to see how your liver and kidneys are functioning.
You will receive the following drugs before and after the allogeneic stem cell transplant:
Neupogen (G-CSF) injections, drugs to prevent infections, Tacrolimus to prevent GVHD and
Methotrexate.
You will have routine and regular follow-up in the transplant clinic after discharge from
the hospital. The following will be performed at each visit:
Physical exam to monitor your health and check for signs of GVHD, infections and any side
effects you may be having; Blood draw for routine blood tests to measure your blood cell
count and chemistry; Blood tests to see if the transplanted stem cells are being accepted
and are growing in the body (engraftment); Bone marrow biopsy to see the status of the
underlying disease (to be done around 100 days after the stem cell transplant).
You will be asked to return to the clinic, at a minimum, for follow-up visits at 6 months, 9
months, 12 months, 18 months and 24 months after your stem cell transplant.
Conditioning is done to kill more cancer cells which may remain as well as prepare your body
for transplant. You will receive the conditioning drugs into a vein. The conditioning
regimen consists of the following drugs: Busulfan and Clofarabine.
While you are in the hospital you will have regular physical exams and you will be asked
specific questions about any problems that you might be having. You will also have blood
tests every day to look at how your bone marrow is recovering, to give possible
transfusional support, and how to see how your liver and kidneys are functioning.
You will receive the following drugs before and after the allogeneic stem cell transplant:
Neupogen (G-CSF) injections, drugs to prevent infections, Tacrolimus to prevent GVHD and
Methotrexate.
You will have routine and regular follow-up in the transplant clinic after discharge from
the hospital. The following will be performed at each visit:
Physical exam to monitor your health and check for signs of GVHD, infections and any side
effects you may be having; Blood draw for routine blood tests to measure your blood cell
count and chemistry; Blood tests to see if the transplanted stem cells are being accepted
and are growing in the body (engraftment); Bone marrow biopsy to see the status of the
underlying disease (to be done around 100 days after the stem cell transplant).
You will be asked to return to the clinic, at a minimum, for follow-up visits at 6 months, 9
months, 12 months, 18 months and 24 months after your stem cell transplant.
Inclusion Criteria:
- Must have well-matched adult donor willing to donate peripheral blood stem cells with
well-matched defined as 8/8 matched related or unrelated donor
- Adequate organ functioning
Exclusion Criteria:
- Pregnant or breastfeeding
- Psychiatric disease severely impairing the compliance of the patient to participate
in the study and/or give informed consent
- Evidence of prior exposure to HIV or HCV
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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