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Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia Clinical research trials and Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia. Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia clinical trial. Human subjects often get the best healthcare available for their Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.

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Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia



Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia

For Condition: childhood Hodgkin's lymphoma,hematopoietic and lymphoid cancer,childhood non-Hodgkin's lymphoma,Graft Versus Host Disease
Status: Recruiting
Sponsor(s): Roswell Park Cancer Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy or radiation therapy. Giving sargramostim to the stem cell donor and the patient may reduce the chance of developing graft-versus-host disease following stem cell transplantation. PURPOSE: Clinical trial to study the effectiveness of sargramostim in decreasing graft-versus-host disease in patients who are undergoing donor stem cell transplantation for hematologic cancer or aplastic anemia.
Details: OBJECTIVES: - Determine the efficacy of sargramostim (GM-CSF) to mobilize CD34+ hematopoietic stem cells in donors and to reduce graft-vs-host disease in patients after allogeneic stem cell transplantation (SCT) for hematologic malignancy or aplastic anemia. - Determine the safety of GM-CSF after allogeneic SCT transplantation in these patients. OUTLINE: This is a pilot study. - Donors receive sargramostim (GM-CSF) subcutaneously (SC) once daily on days 1-6. Donors undergo stem cell harvest on day 7. Donors may undergo up to 3 apheresis procedures to reach the target stem cell dose and may receive additional GM-CSF prior to each collection. - Patients: Patients receive conditioning therapy as per transplantation protocol RP98-15. Patients undergo allogeneic stem cell transplantation on day 0. Patients then receive GM-CSF SC once daily beginning on day 7 and continuing until blood counts recover. Patients are followed weekly until day 100 and then at days 180 and 360. PROJECTED ACCRUAL: A total of 10 patients and 10 donors will be accrued for this study.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 5 Years/60 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of a malignant hematologic disease, including: - Acute or chronic leukemia - Myelodysplastic syndromes - Myeloproliferative disorder - Hodgkin's lymphoma - Non-Hodgkin's lymphoma OR - Aplastic anemia - Planned transplantation on an RPCI IRB-approved allogeneic stem cell transplantation protocol - HLA-matched (6/6) related donor available PATIENT CHARACTERISTICS: Age - 5 to 60 Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients and donors must use effective contraception - No known allergy to GM-CSF - No prior of adverse reaction to any yeast recombinant molecule PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No prior allogeneic stem cell transplantation Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
PhilipMcCarthy,  Study Chair,  Roswell Park Cancer Institute

Roswell Park Cancer Institute *Recruiting*
Buffalo,  New York,  14263-0001
United States
Recruiting Philip  McCarthy 716-845-8707


Additional Information:
Study ID Numbers:
  CDR0000269288;  RPCI-RPC-0201
Study Start Date: 
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053157

Other Hematopoietic And Lymphoid Cancer Studies:
1. Cyclophosphamide Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

2. Donor Stem Cell Transplantation in Treating Patients With Relapsed Hematologic Cancer

3. Total-Body Irradiation and Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer or Kidney Cancer

4. Total-Body Irradiation With Or Without Fludarabine Followed By Allogeneic Hematopoietic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies

5. Combining Chemotherapy, Tacrolimus, Mycophenolate Mofetil, and Radiation Therapy with Donor Bone Marrow Transplantation in Treating Patients with Hematologic Cancer

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