Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00054327
• Date of registration: 05/02/2003
• Prospective Registration: No
• Primary sponsor: Case Comprehensive Cancer Center
• Public title: Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
• Scientific title: Hematopoietic Stem Cell Transplantation Using Bone Marrow Or Peripheral Blood Stem Cells From Matched, Unrelated, Volunteer Donors
• Date of first enrolment: November 2000
• Target sample size: 34
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00054327
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Kenneth Cooke, MD
• Affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Key inclusion & exclusion criteria

Eligibility Criteria:

1. Patients with histologic confirmation of the following diseases are eligible:

1. AML in first, second or greater remission

2. AML in early relapse, defined at <30% marrow blasts

3. ALL in second or greater complete remission

4. High risk ALL in first complete remission, with high risk being defined by the
presence of t(4;11), t(9;22), or t(8;14) translocation, or patients presenting
with extreme hyperleukocytosis (initial WBC >500 K/ml) or failure to achieve a
complete remission after standard induction therapy.

5. CML

6. Myelodysplastic syndromes (including evolution to AML, e.g., Refractory Anemia
with Excess Blasts (RAEB), or Refractory Anemia with Excess Blasts in
transformation (RAEB-t).

7. Lymphoma (intermediate and high grade) chemosensitive (CR or PR) after first or
greater relapse or chemosensitive to first line therapy but only achieving PR.

8. Hematologic Disease and Inherited Immunodeficiencies

9. Hodgkin's disease, relapsed or refractory to standard treatments.

2. Patients must be less than or equal to 55 years of age.

3. Patients (or guardians if minor) must be able to give informed consent. Children older
than 11 years of age must assent to the process.

4. Patients or their guardians must demonstrate proof-of-payment.

5. Patients must have an ECOG Performance Status of 2 or less. (See Appendix I)

6. Patients must have no evidence of active infection at the time of transplantation.

7. Patients must be HIV nonreactive.

8. Patients must have a pre-transplant, multi-organ assessment prior to transplantation
with the following outcome:

1. resting ejection fraction of 50% or greater (or shortening fraction greater than
28% for small children).

2. Diffusion capacity of 50% or greater of predicted, a FEV1 of 50% or greater, and
a P2O of 80 mm Hg as demonstrated on pulmonary function testing.

3. serum creatinine of less than or equal to 2.0 mg/dL and/or a corrected creatinine
clearance of 50 ml/min or greater on 24 hr urine.

4. A total bilirubin of less than 2.5 mg/dL and an AST less than 4 times the upper
limits of normal.

9. Females who are childbearing age may not be pregnant or lactating and must have a
current negative pregnancy test

Ineligibility Criteria:

- Patients who have a life expectancy of less than three months with therapy.

- Patients who have an ECOG performance status greater than 2, (See Appendix I) or
Lansky Scale < 70%.

- Patients who have angina and/or congestive heart failure requiring treatment, or who
have had a myocardial infarction within the past year.

- Patients who have a resting ejection of less than 50% (or shortening fraction less
than 28%) and who have not been cleared for transplant by cardiology

- Patients who have severe renal disease as demonstrated by a serum creatinine greater
than 2.0 mg/dL and/or a corrected creatinine clearance less than 50 ml/min. (corrected
for BSA of 1.73 m¬2)

- Patients who have had any complication that makes the risk of death during
transplantation from non-malignant causes greater than the risk of relapse.

- Patients who have any active infection such as a soft tissue infection, sinus
infection, dental infection, fungal infection or hepatitis including chronic active
hepatitis; if the infection is successfully treated, the patient may be reconsidered
for transplantation at a later date.

- Patients who have decreased pulmonary function due to any disorder as demonstrated by
a diffusion capacity of less than 50% of predicted, a FEV1 of less than 50% of
predicted or a PO2 of less than 80 mm Hg pulmonary function testing.

- Patients who have decreased liver function as demonstrated by a total bilirubin of
greater than 2.5 mg/dL and/or an AST greater than 4 times the upper limits of normal.

- Patients who have diabetes mellitus will be considered on a case-by-case basis.
However, patients with diabetes who are not controlled by medical management will be
ineligible.

-Patients who have a significant psychiatric illness will be considered on a case- by-case
basis. With the patient's consent, their Mental Health Care worker will assist the managing
transplant physicians in determining if the patient can safely undergo transplantation and
comply with followup recommendations.

- Psychosocial assessment by the bone marrow transplant team may identify individuals
for whom this form of therapy may be contraindicated. This decision will be based upon
estimated adequacy of patient support systems and prediction of patient's compliance
with medications, required diagnostic procedures and/or follow-up care.

- Females who are childbearing age may not be pregnant or lactating and must have a
current negative pregnancy test

- Patients who had a stem cell transplant less than one year earlier



Age minimum: N/A
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Myelodysplastic Syndromes

Lymphoma

Leukemia

Myelodysplastic/Myeloproliferative Diseases

Intervention(s)

Drug: cytarabine

Procedure: Stem Cell Transfusion

Drug: cyclophosphamide

Radiation: radiation therapy

Drug: busulfan

Drug: Etoposide

Primary Outcome(s)

Rates of Durable Engraftment [Time Frame: at day 42]

Secondary Outcome(s)

Toxicity as Measured by CTC v2.0 [Time Frame: at 100 days post transplant]

Incidence of Recurrent Disease [Time Frame: at day 100 post transplant]

Graft-versus-host Disease (GVHD) [Time Frame: at 100 days post transplant]

Secondary ID(s)

CWRU1Y00

CASE-CWRU-1Y00

P30CA043703

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)

Results

• Results available: Yes
• Date Posted: 24/07/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00054327