Overview

Thiotepa-Clofarabine-Busulfan With Allogeneic Stem Cell Transplant for High Risk Malignancies

Status:
Completed
Trial end date:
2019-03-09
Target enrollment:
0
Participant gender:
All
Summary
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn if thiotepa, busulfan, and clofarabine, when given before an allogeneic (bone marrow , blood, or cord blood cells) or haploidentical (bone marrow) stem cell transplantation can help to control cancers of the bone marrow and lymph node system. The safety of this treatment will also be studied. This is an investigational study. Thiotepa and clofarabine are FDA approved and commercially available for the treatment of leukemia. Busulfan is FDA approved and commercially available for use in stem cell transplantation. The combination of thiotepa, clofarabine, and busulfan together with a stem cell transplant is investigational. Up to 60 participants will take part in this study. All will be enrolled at M. D. Anderson.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Antilymphocyte Serum
Busulfan
Clofarabine
Cyclophosphamide
Lenograstim
Mesna
Methotrexate
Tacrolimus
Thiotepa
Thymoglobulin
Criteria
Inclusion Criteria:

1. Diagnosed with one of the following diseases:

2. Acute myelogenous leukemia (AML) in induction failure, relapse, past first remission,
or CR1 considered at risk for relapse

3. Myelodysplastic syndromes with International Prognostic Scoring System score (IPSS
score) >/= 2 or myelodysplasia that has not responded to chemotherapy

4. Biphenotypic leukemia

5. Acute lymphocytic leukemia with induction failure, first complete remission with high
risk cytogenetics (e.g. Philadelphia positive chromosome, t(4:11) Remission requiring
more than 2 chemotherapy to achieve remission, or any stage beyond CR1

6. Chronic Myelogenous Leukemia (CML): second chronic phase, accelerated phase or blast
crises with less than 10% blasts in the bone marrow, or CR1 and resistance to Gleevec
or other tyrosine kinase inhibitors

7. Non-Hodgkin's Lymphoma - induction failures, second or third complete remission, or
relapse (including relapse post autologous hematopoietic stem cell transplant)

8. Hodgkin's disease - induction failure, second or later complete remission, or relapse
(including relapse post autologous hematopoietic stem cell transplant).

9. Chronic Lymphocytic Leukemia that has failed induction therapy or Rai Stages 2-4

10. Related or unrelated donor which is HLA-matched or mismatched in 1 HLA A, B, C, DR, or
DQ locus is acceptable (i.e. >/= 9/10 matched related or unrelated donor, matched with
molecular high-resolution technique per current std. for BMT program). Cord blood
units must match patient at 4, 5, or 6/6 HLA class 1 serological & II molecular
antigens with a min. of 2 x 10e7 TNC/kg recipient weight in the pre-thawed fraction.
For patient lacking a matched related or unrelated donor or acceptable cord blood
unit(s), a related haploidentical donor ( may be used.

11. Age
12. Lansky performance score >/= 50% for patients performance status score of 0-2 for patients > 16 years of age.

13. Cardiac function - left ventricular ejection fraction >/= 40%.

14. Pulmonary function - diffusion capacity of at least 50% predicted. Children unable to
perform pulmonary function tests (e.g. less than 7 years old) pulse oximetry of >/=
92% on room air.

15. Serum creatinine < 1.6 mg/dL or creatinine clearance >/= 50 ml/min.

16. SGPT
17. Written informed consent and assent as is age appropriate.

18. No active infection.

Exclusion Criteria:

1. Pregnancy in women of child bearing potential (pregnancy test performed within 2 weeks
of study entry).

2. HIV positive (highly immunosuppressive treatment)

3. Active CNS leukemia

4. Chronic or active Hepatitis B or Hepatitis C. If questions about liver health discuss
with PI and strongly consider liver biopsy.