BridgeMD
New treatment option for Anaplastic Large Cell Lymphoma, ALK-Negative
Official title Testing Whether High Dose Chemotherapy and Infusion of the Patients' Own Stem Cells Improves Survival in Patients With Peripheral T-cell Lymphoma Who Achieved a Complete Response at the End of the Initial Chemotherapy
ClinicalTrials.gov ID: NCT06724237
What this study is testing
What is High Dose Chemotherapy?
High Dose Chemotherapy is an investigational medicine, being studied as a potential treatment for anaplastic large cell lymphoma, alk-negative.
Also referred to as high-dose chemotherapy.
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 III trial compares the effect of high dose chemotherapy and the patients' own (autologous) stem cells to observation only in patients with peripheral T-cell lymphoma who achieved a complete response after initial chemotherapy. Usual treatment after a complete response may include observation or high dose chemotherapy followed by an autologous stem cell transplant, however, it is not known if a transplant if beneficial.
- Phase 3: a large, late-stage study
- Time commitment: about 7 years
- Which group you join is decided by chance.
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 75
You may be able to join if
- Patient must be 18 to 75 years of age
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patient must have histologically proven peripheral T-cell lymphoma (PTCL) in one of the following categories:
- Anaplastic large cell lymphoma (ALCL) ALK-negative
- Angioimmunoblastic T-cell lymphoma (AITL)
See the full eligibility criteria
- Patient must be 18 to 75 years of age
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patient must have histologically proven peripheral T-cell lymphoma (PTCL) in one of the following categories:
- Anaplastic large cell lymphoma (ALCL) ALK-negative
- Angioimmunoblastic T-cell lymphoma (AITL)
- Nodal PTCL with follicular helper T cell (TFH) phenotype
- Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)
- Patient must have undergone induction treatment with an anthracycline based chemotherapy.
- NOTE: Patients who discontinued anthracycline during treatment are eligible as long as they received at least one dose and achieved complete remission
- Patient must have achieved radiologic complete remission following induction therapy as defined by the Lugano criteria with a Deauville score between 1-3 by PET-CT
- NOTE: There is no central review required. Confirmation of complete remission status is determined by the enrolling institution's review
- NOTE: If a patient had a positive bone marrow biopsy at the time of initial diagnosis (pre-induction), a repeat biopsy must be completed post induction to confirm complete remission (CR)
- Patient must be eligible for high dose chemotherapy and autologous stem cell transplant (ASCT) per the enrolling institutional guidelines at the transplant center and be ready to proceed with ASCT if assigned by chance...
- Patient must not have active infection requiring intravenous systemic antimicrobial at time of randomization. Antibiotic prophylaxis is acceptable as long as the dose of the medication has been stable for at least 7...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing...
- Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse during the treatment phase of the study and thereafter according...
- Absolute neutrophil count (ANC) ≥ 1000/mcL (obtained ≤ 14 days prior to protocol randomization)
- Platelets ≥ 75,000/mcL (obtained ≤ 14 days prior to protocol randomization)
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained ≤ 14 days prior to protocol randomization)
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) ≤ 3.0 x institutional ULN (obtained ≤ 14 days prior to protocol...
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Anchorage, Alaska, United States
- Fairbanks, Alaska, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Burbank, California, United States
- Duarte, California, United States
- Irvine, California, United States
- Martinez, California, United States
- Napa, California, United States
- Orange, California, United States
- Santa Rosa, California, United States
- Walnut Creek, California, United States
- Aurora, Colorado, United States
- Boulder, Colorado, United States
- Centennial, Colorado, United States
- Denver, Colorado, United States
- Englewood, Colorado, United States
- Lakewood, Colorado, United States
- Littleton, Colorado, United States
+ 100 more site(s).
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 study runs about 7 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Anchorage, Alaska, United States; Fairbanks, Alaska, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Burbank, California, United States and 114 more location(s). 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.