Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-26 @ 3:56 PM
Study NCT ID:
NCT00800150
Status:
TERMINATED
Last Update Posted:
2015-06-08
First Post:
2008-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total Marrow and Total Lymph Node Irradiation, Fludarabine, and Melphalan Followed By Donor Stem Cell Transplant in Treating Patients With Advanced Hematological Cancer That Has Not Responded to Treatment
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
Phase I Study of Escalating Doses of Radiation Therapy Using Helical Tomotherapy in Combination With Fludarabine (FLU) and Melphalan (MEL) as a Preparative Regimen for Allogeneic Hematopoietic Stem Cell (HSC) Transplantation in Patients With Advanced and Hematological Malignancies Who Are Not Eligible for Fully Myeloablative Regimen
Status:
TERMINATED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Protocol objective could not be met. A new study with amended eligibility criteria will be developed.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Giving total marrow and total lymph node irradiation together with low doses of chemotherapy 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).
PURPOSE: This phase I trial is studying the side effects and best dose of total marrow and total lymph node irradiation when given together with fludarabine and melphalan followed by donor stem cell transplant in treating patients with advanced hematological cancer that has not responded to treatment.
PURPOSE: This phase I trial is studying the side effects and best dose of total marrow and total lymph node irradiation when given together with fludarabine and melphalan followed by donor stem cell transplant in treating patients with advanced hematological cancer that has not responded to treatment.
Detailed Description:
OBJECTIVES:
Primary
* To determine the maximum tolerated dose of intensity-modulated total marrow and lymph node irradiation (TMLI) using helical tomotherapy in combination with a reduced-intensity preparative regimen comprising fludarabine phosphate and melphalan in patients undergoing allogeneic hematopoietic stem cell transplantation for advanced, relapsed or refractory hematological malignancies.
* To describe the toxicities of escalating doses of TMLI in these patients.
Secondary
* To describe the frequency of clinical response in patients treated with this regimen.
* To describe the frequency of primary and secondary engraftment failure in patients treated with this regimen.
* To describe the time to neutrophil and platelet engraftment in patients treated with this regimen.
* To describe the incidence of acute and chronic graft-versus-host disease in patients treated with this regimen.
* To describe the overall survival of patients treated with this regimen.
* To describe the progression-free survival of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of intensity-modulated total marrow and lymph node irradiation (TMLI).
* Intensity-modulated radiation therapy: Patients undergo TMLI to skeletal bone/marrow, major lymph node chains, spleen, and liver using helical tomotherapy twice daily on days -6 to -3.
* Reduced-intensity preparative regimen: Patients receive fludarabine phosphate IV on days -6 to -2 and melphalan IV on day -1.
* Hematopoietic stem cell transplantation (HSCT): Patients undergo allogeneic HSCT on day 0.
After completion of study treatment, patients are followed periodically.
Primary
* To determine the maximum tolerated dose of intensity-modulated total marrow and lymph node irradiation (TMLI) using helical tomotherapy in combination with a reduced-intensity preparative regimen comprising fludarabine phosphate and melphalan in patients undergoing allogeneic hematopoietic stem cell transplantation for advanced, relapsed or refractory hematological malignancies.
* To describe the toxicities of escalating doses of TMLI in these patients.
Secondary
* To describe the frequency of clinical response in patients treated with this regimen.
* To describe the frequency of primary and secondary engraftment failure in patients treated with this regimen.
* To describe the time to neutrophil and platelet engraftment in patients treated with this regimen.
* To describe the incidence of acute and chronic graft-versus-host disease in patients treated with this regimen.
* To describe the overall survival of patients treated with this regimen.
* To describe the progression-free survival of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of intensity-modulated total marrow and lymph node irradiation (TMLI).
* Intensity-modulated radiation therapy: Patients undergo TMLI to skeletal bone/marrow, major lymph node chains, spleen, and liver using helical tomotherapy twice daily on days -6 to -3.
* Reduced-intensity preparative regimen: Patients receive fludarabine phosphate IV on days -6 to -2 and melphalan IV on day -1.
* Hematopoietic stem cell transplantation (HSCT): Patients undergo allogeneic HSCT on day 0.
After completion of study treatment, patients are followed periodically.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA033572 | NIH | None | https://reporter.nih.gov/quic… | View |
| CHNMC-08076 | None | None | View | |
| CDR0000626148 | REGISTRY | NCI PDQ | View |