Clinical Trials

Clinical Trial Detail

Return to search results.

Treosulfan, Fludarabine Phosphate, and Total Body Irradiation Before Donor Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia

Complete title: A Randomized Phase II Study of Treosulfan, Fludarabine and Low-Dose TBI as Conditioning for Allogeneic Hematopoietic Cell Transplantation in Patients with Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML)

Research Study Number       2524.00
Principal Investigator       Joachim Deeg, MD
Phase       II

Look up trial at NIH

Research Study Description

This phase II trial studies how well treosulfan, fludarabine phosphate, and total body irradiation before donor stem cell transplant works in treating patients with myelodysplastic syndrome or acute myeloid leukemia. Giving chemotherapy, such as treosulfan and fludarabine phosphate, and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus before and mycophenolate mofetil after the transplant may stop this from happening.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: up to 70 Years

Genders Eligible for Study: Both

- MDS, myelodysplastic syndrome/myeloproliferative neoplasia overlap disorders (including chronic myelomonocytic leukemia [CMML], and MDS/myeloproliferative neoplasm [MPN] unclassifiable syndromes)

- AML, other than acute promyelocytic leukemia (APL), in first or second remission or with minimal residual disease

- With Karnofsky index or Lansky Play-Performance scale > 70% on pre-transplant evaluation

- Able to give informed consent (if > 18 years), or with a legal guardian capable of giving informed consent (if < 18 years)

- Patients with previous autologous or allogeneic HCT are allowed to enroll

- DONOR: Human leukocyte antigen (HLA)-identical related donors or

- DONOR: Unrelated donors matched for HLA-A, B, C, DRB1, and DQB1 as defined by high resolution deoxyribonucleic acid (DNA) typing; mismatch for one HLA allele is allowed

- DONOR: Donors able to undergo peripheral blood stem cell collection or bone marrow harvest

- DONOR: Donors in good general health, with a Karnofsky or Lansky play performance score > 90%

- DONOR: Donors able to give informed consent (if > 18 years), or with a legal guardian capable of giving informed consent (if < 18 years)

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- Receiving umbilical cord blood

- With impaired cardiac function as evidenced by ejection fraction < 35% (or, if unable to obtain ejection fraction, shortening fraction of < 26%) or cardiac insufficiency requiring treatment or symptomatic coronary artery disease; patients with a shortening fraction < 26% may be enrolled if approved by a cardiologist

- With impaired pulmonary function as evidenced by partial pressure of oxygen (pO2) < 70 mm Hg and carbon monoxide diffusing capability test (DLCO) < 70% of predicted or pO2 < 80 mm Hg and DLCO < 60% of predicted; (or, for pediatric patients unable to perform pulmonary function tests, then oxygen (O2) saturation < 92% on room air), or receiving supplementary continuous oxygen

- With impaired renal function as evidenced by creatinine-clearance < 50% for age, weight, height or serum creatinine > 2 x upper limit of normal or dialysis-dependent

- With hepatic dysfunction as evidenced by total bilirubin > 2.0 x upper limit of normal or evidence of synthetic dysfunction or severe cirrhosis

- With hepatic dysfunction as evidenced by aspartate aminotransferase (AST) > 2.0 x upper limit of normal or evidence of synthetic dysfunction or severe cirrhosis

- With active infectious disease requiring deferral of conditioning, as recommended by an infectious disease specialist

- With human immunodeficiency virus (HIV)-positivity or active infectious hepatitis

- With central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy, cranial irradiation or both prior to initiating conditioning (day -6)

- Patients with active non-hematological malignancies (except non-melanoma skin cancers) or those with non-hematological malignancies who have been rendered with no evidence of disease, but have a greater than 20% chance of having disease recurrence within 5 years; this exclusion does not apply to patients with non-hematologic malignancies that do not require therapy

- With life expectancy severely limited by diseases other than malignancy

- Women who are pregnant or lactating

- With known hypersensitivity to treosulfan or fludarabine (fludarabine phosphate)

- Receiving another experimental drug within 4 weeks before initiation of conditioning (day -6)

- Unable to give informed consent (if > 18 years) or with a legal guardian (if < 18 years) unable to give informed consent

- DONOR: Individuals deemed unable to undergo marrow harvesting or PBSC mobilization and leukapheresis

- DONOR: Individuals who are HIV-positive

- DONOR: Individuals with active infectious hepatitis

- DONOR: Females with a positive pregnancy test

- DONOR: Persons unable to give informed consent (if > 18 years) or with a legal guardian (if < 18 years) unable to give informed consent

Other exclusion criteria may apply.

Research Study Number       2524.00
Contact       Seattle Cancer Care Alliance Intake Office
Telephone       800-804-8824 / 206-288-1024

Leukemia, Acute Myeloid (AML); Hematologic Malignancies; Leukemia; Myelodysplastic Syndromes (MDS); Leukemia, Myeloid; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Chronic Myelomonocytic (CMML); Leukemia, Acute Myelomonocytic (AML-M4); Preleukem

Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

Subscribe to an RSS feed of all trials