Thiotepa Plus Fludarabine+ Melphalan as the Preparative Regime for Alternative Donor Transplantation

PHASE2CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

March 21, 2018

Primary Completion Date

June 12, 2024

Study Completion Date

June 12, 2024

Conditions
Leukemia
Interventions
DRUG

Melphalan

"Alkylating agent which is a derivative of mechlorethamine that inhibits DNA and RNA synthesis via formation of carbonium ions; cross-links strands of DNA; acts on both resting and rapidly dividing tumor cells.~Melphalan may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash."

DRUG

Thiotepa

"Thiotepa is an alkylating agent which produces cross-linking of DNA strands leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent.~Thiotepa may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash."

DRUG

Fludarabine

"Fludarabine is an antineoplastic fluorinated nucleoside analog and inhibits DNA synthesis through inhibition of polymoerase alpha after incorporation into DNA.~Fludarabine may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash, and lower limb weakness."

Trial Locations (1)

44106-5065

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
lead

Case Comprehensive Cancer Center

OTHER

NCT03342196 - Thiotepa Plus Fludarabine+ Melphalan as the Preparative Regime for Alternative Donor Transplantation | Biotech Hunter | Biotech Hunter