AML Clinical Trial
Official title:
Busulfan, Cyclophosphamide, and Melphalan Followed by Allogeneic Hematopoietic Cell Transplantation in Patients With Hematological Malignancies
Verified date | December 2017 |
Source | Masonic Cancer Center, University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This protocol using busulfan, cyclophosphamide and melphalan has been designed as conditioning therapy for patients receiving stem cell transplantation for acute leukemia or myelodysplastic syndrome (MDS). The hypothesis is that this new regimen will be well tolerated and will cure the patient.
Status | Terminated |
Enrollment | 11 |
Est. completion date | February 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 35 Years |
Eligibility |
Inclusion Criteria: - Patients must have a diagnosis of acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and currently be in complete remission. - Patients must be either: - - <18 years of age who are at least 6 months after initial hematopoietic cell transplant (HCT), - - 19-35 years of age and at least 18 months after initial HCT, or - - <35 years of age and have received sufficient radiation treatment to be ineligible for total body irradiation (TBI) containing preparative therapy - Adequate major organ function including: - - Cardiac: ejection fraction > or = 45% - - Renal: creatinine clearance > or = 40 mL/min - - Hepatic: no clinical evidence of hepatic failure (e.g. coagulopathy, ascites) - - Karnofsky performance status > or = 70% or Lansky score > or = 50% - Women of child bearing age must be using adequate birth control and have a negative pregnancy test. - Written informed consent. Exclusion Criteria: - Eligible for TBI containing preparative regimen. - Active uncontrolled infection within one week of HCT. - Pregnant or lactating females. |
Country | Name | City | State |
---|---|---|---|
United States | Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Masonic Cancer Center, University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Probability of Long-term Disease-free Survival (DFS) | Number of participants with long-term disease free survival after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies. | 1 year | |
Secondary | Probability of Engraftment | Number of participants with engraftment after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.. | 1 year | |
Secondary | Incidence of Acute Graft-versus-host Disease (GVHD) | Number of participants with acute GVHD after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies. | 100 days post-transplant | |
Secondary | Incidence Chronic Graft-versus-host Disease (GVHD) | Number of participants with chronic GVHD after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies. | 1 year | |
Secondary | Incidence of Regimen-related Toxicity 100 Days Post Transplant | Number of participants with regimen-related toxicity 100 days post transplant after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies. | 100 days post-transplant | |
Secondary | Incidence of Relapse | Number of patients with relapse after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies. | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03118466 -
Mitoxantrone, Etoposide, and Cytarabine (MEC) Plus Lenalidomide for Relapsed or Refractory Acute Myeloid Leukemia
|
Phase 2 | |
Not yet recruiting |
NCT06313437 -
Revumenib in Combination With 7+3 + Midostaurin in AML
|
Phase 1 | |
Withdrawn |
NCT03444649 -
Epacadostat, Idarubicin and Cytarabine (EIC) in AML
|
Phase 1 | |
Withdrawn |
NCT02905994 -
Volasertib Combined With Induction Chemotherapy in Acute Myeloid Leukemia
|
Phase 1 | |
Recruiting |
NCT02261779 -
Phase I/II Trial of ATRA and TCP in Patients With Relapsed or Refractory AML and no Intensive Treatment is Possible
|
Phase 1/Phase 2 | |
Completed |
NCT00246649 -
Stem Cell Transplant With Specially Treated Cells in Treating Patients With Acute Leukemia
|
N/A | |
Completed |
NCT00333190 -
CD8+ T Cell Depletion for GVHD Prophylaxis After Peripheral Blood Stem Cell Transplantation
|
N/A | |
Terminated |
NCT04079738 -
Study Augmenting TAK-659 Action in Relapsed/Refractory AML by Addition Ofthe Proteasome Inhibitor Ixazomib
|
Phase 1/Phase 2 | |
Completed |
NCT03466320 -
DEPLETHINK - LymphoDEPLEtion and THerapeutic Immunotherapy With NKR-2
|
Phase 1/Phase 2 | |
Withdrawn |
NCT03138395 -
iCare3: Monitoring Circulating Cancer DNA After Chemotherapy in MDS and AML
|
N/A | |
Terminated |
NCT01570465 -
Prospective Study on Severe Infections on Acute Myeloid Leukemia (AML) Patients
|
||
Completed |
NCT04443751 -
A Safety and Efficacy Study of SHR-1702 Monotherapy in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
|
Phase 1 | |
Terminated |
NCT03761069 -
Study of PTC299 (Emvododstat) in Relapsed/Refractory Acute Leukemias
|
Phase 1 | |
Completed |
NCT02631993 -
Photochemotherapy and Graft-versus-leukemia in Acute-leukemia
|
N/A | |
Completed |
NCT02575963 -
Lintuzumab-Ac225 in Older Acute Myeloid Leukemia (AML) Patients
|
Phase 1/Phase 2 | |
Completed |
NCT00863148 -
Allogeneic Stem Cell Transplant With Clofarabine, Busulfan and Antithymocyte Globulin (ATG) for Adult Patients With High-risk Acute Myeloid Leukemia/Myelodysplastic Syndromes (AML/MDS) or Acute Lymphoblastic Leukemia (ALL)
|
Phase 2 | |
Completed |
NCT00780598 -
Safety and Anti-Disease Activity of Oral Tosedostat (CHR-2797) in Elderly Subjects With Refractory or Relapsed AML
|
Phase 2 | |
Completed |
NCT00761449 -
Lenalidomide in High-risk MDS and AML With Del(5q) or Monosomy 5
|
Phase 2 | |
Completed |
NCT00542971 -
Phase I-II Study of Idarubicin, Cytarabine, and Sorafenib (BAY43-9006)
|
Phase 1/Phase 2 | |
Completed |
NCT00589082 -
DaunoXome + Ara-C vs Daunorubicin + Ara-C in Elderly AML
|
Phase 3 |