BridgeMD
New treatment option for Hematopoietic and Lymphoid System Neoplasm
Official title Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant
ClinicalTrials.gov ID: NCT04022239
What this study is testing
What is Bendamustine?
Bendamustine is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for hematopoietic and lymphoid system neoplasm.
Also referred to as SDX-105.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase I/II trial studies the side effects and best dose of bendamustine when given with or without cyclophosphamide in preventing graft versus host disease (GVHD) in patients undergoing stem cell transplant. Drugs used in chemotherapy, such as bendamustine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Patient with hematologic malignancies.
- Donor: Matched sibling, matched unrelated, mismatched or haploidentical
- Zubrod performance 0 to 2 or Karnofsky of at least 60.
- Adequate organ function at time of study entry:
- Creatinine less than or equal to 1.6 mg/dL and creatinine clearance \>/= 30 ml/min. Creatinine clearance will be calculated using the Cockcroft-Gault...
You likely can't join if
- Pregnant or nursing women.
- Known to be HIV positive
- Active and uncontrolled disease/infection
- Unable or unwilling to sign consent
- Current active hepatic or biliary disease (with exception of Gilbert's syndrome)
- Active hepatitis B or C.
See the full eligibility criteria
- Patient with hematologic malignancies.
- Donor: Matched sibling, matched unrelated, mismatched or haploidentical
- Zubrod performance 0 to 2 or Karnofsky of at least 60.
- Adequate organ function at time of study entry:
- Creatinine less than or equal to 1.6 mg/dL and creatinine clearance \>/= 30 ml/min. Creatinine clearance will be calculated using the Cockcroft-Gault equation
- Total bilirubin less than \< 1.5 x UNL
- SGPT \< 2.5 x ULN
- Ejection fraction \>/= 40%
- FEV1, FVC and DLCO \>/= 40%
- Female patients of childbearing potential must agree to use an effective method of birth control while on study and for 6 months after the last dose of bendamustine. Male patients with female partners of childbearing...
- Pregnant or nursing women.
- Known to be HIV positive
- Active and uncontrolled disease/infection
- Unable or unwilling to sign consent
- Current active hepatic or biliary disease (with exception of Gilbert's syndrome)
- Active hepatitis B or C.
- Toxicities (grade \> 1) unresolved from prior treatment (including chemotherapy, targeted therapy, immunotherapy, experimental agents radiation, or surgery.
- Patients with standard risk acute leukemia in first complete remission and patients with chronic myeloid leukemia in first chronic will be excluded during escalated phase.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.