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NCT00800150
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
Phase 1 trial testing fludarabine phosphate in Chronic Myeloproliferative Disorders in 6 participants. Terminated before completion.
1 October 2010
Quick facts
| Lead sponsor | City of Hope Medical Center |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 1 November 2008 |
| Primary completion | 1 October 2010 |
| Estimated completion | 1 October 2010 |
| Sites | 1 location across United States |
Drugs / interventions tested
- fludarabine phosphate (FLUDARABINE PHOSPHATE) — full drug profile →
- melphalan (melphalan) — full drug profile →
- nonmyeloablative allogeneic hematopoietic stem cell transplantation
- intensity-modulated radiation therapy
- tomotherapy
- total marrow irradiation
- total nodal irradiation
Conditions studied
- Chronic Myeloproliferative Disorders — all drugs for Chronic Myeloproliferative Disorders →
- Leukemia — all drugs for Leukemia →
- Lymphoma — all drugs for Lymphoma →
- Multiple Myeloma and Plasma Cell Neoplasm — all drugs for Multiple Myeloma and Plasma Cell Neoplasm →
Sponsor
City of Hope Medical Center
Who can join
16 and older, any sex, with Chronic Myeloproliferative Disorders or Leukemia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- Maximum tolerated dose of intensity-modulated total marrow and lymph node irradiation using helical tomotherapy
- Toxicity
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Melphalan-Based Reduced-Intensity Conditioning is Associated with Favorable Disease Control and Acceptable Toxicities in Patients Older Than 70 with Hematologic Malignancies Undergoing Allogeneic Hematopoietic Stem Cell Transplantation.
Al Malki MM, Nathwani N, Yang D, Armenian S, et al · · 2018 · cited 18× · PMID 29753158 · DOI 10.1016/j.bbmt.2018.04.029
Verify or expand the search:
- PubMed search for NCT00800150
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of fludarabine phosphate
Trials testing the same drug.
- NCT06904066 — Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients W · Phase 1 · recruiting
- NCT02181478 — Intra-Osseous Co-Transplant of UCB and hMSC · EARLY_PHASE1 · completed
- NCT02248597 — Donor Stem Cell Transplant Followed by Cyclophosphamide in Treating Patients With Hematological Diseases · Phase 2 · completed
- NCT02129582 — Targeted Marrow Irradiation, Fludarabine Phosphate, and Busulfan Before Donor Progenitor Cell Transplant in Treating Pat · Phase 1 · completed
- NCT02070406 — Gene-Modified T Cells, Vaccine Therapy, and Ipilimumab in Treating Patients With Locally Advanced or Metastatic Malignan · Phase 1 · terminated
Other recruiting trials for Chronic Myeloproliferative Disorders
Currently open trials in the same condition.
- NCT00544115 — Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders · Phase 2 · active not recruiting
Other City of Hope Medical Center trials
Trials by the same sponsor.
- NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant · Phase 2 · not yet recruiting
- NCT07218692 — RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy · Phase 2 · not yet recruiting
- NCT07363408 — Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment · Phase 1 · not yet recruiting
- NCT07226102 — Virtual Mental Health Intervention to Address Fear of Progression for Women With High Risk or Stage III-IV Gynecologic o · NA · withdrawn
- NCT07225855 — Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Can · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00800150 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by City of Hope Medical Center
- Last refreshed: 3 June 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00800150.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing