University of Kansas Medical Center

Conditions

• Anaplastic Large Cell Lymphoma, ALK-Negative
• Follicular Helper T-Cell Lymphoma
• Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type
• Peripheral T-Cell Lymphoma, Not Otherwise Specified

Eligibility

Eligible Ages

Between 18 Years and 75 Years

Eligible Sex

All

Accepts Healthy Volunteers

No

Criteria

Inclusion 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 randomized to the ASCT arm

- 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 days prior to randomization

- Patients with a prior or concurrent malignancy whose natural history or treatment
does not have the potential to interfere with the safety or efficacy assessment of
the investigational regimen are eligible for this trial

- 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 potential must have a
blood test or urine study within 14 days prior to randomization to rule out
pregnancy. A patient of childbearing potential is defined as anyone, regardless of
sexual orientation or whether they have undergone tubal ligation, who meets the
following criteria: 1) has achieved menarche at some point, 2) has not undergone a
hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal
(amenorrhea following cancer therapy does not rule out childbearing potential) for
at least 24 consecutive months (i.e., has had menses at any time in the preceding 24
consecutive months)

- 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 to institutional
guidelines

- 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 randomization)

- 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

Recruiting Locations

Study Contact

Detailed Description

PRIMARY OBJECTIVE: I. To demonstrate improvement in progression free survival (PFS) in the autologous stem cell transplant (ASCT) arm compared to the observation arm. SECONDARY OBJECTIVES: I. To assess difference in overall survival (OS) between the observation and autologous stem cell transplant (ASCT) arm. II. To evaluate the differences in study intervention benefit for PFS and OS by the randomization stratification factors (histology and choice of induction chemotherapy). III. To evaluate the cumulative incidence of relapse and mortality between the observational and autologous stem cell transplant (ASCT) arm. EXPLORATORY OBJECTIVE: I. To determine the impact of minimal residual disease (MRD) on the benefit of autologous stem cell transplant (ASCT). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive standard of care observation on study. Patients also undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and computed tomography (CT) or positron emission tomography (PET)/CT throughout the study. ARM II: Patients receive stem cell mobilization and then undergo leukapheresis per standard of care. Patients also receive high dose chemotherapy followed by ASCT per standard of care. Additionally, patients undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for up to 7 years for a total of 12 years from the date of randomization.