Chemoimmunotherapy and stem cell transplant for NK T-cell leukemia and lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial involves two cohorts of patients with advanced stage NK-cell leukemia and lymphoma. Cohort 1 receives a modified chemotherapy regimen including dexamethasone, methotrexate, ifosfamide, pegaspargase, and etoposide, along with pembrolizumab. Cohort 2 combines pralatrexate and brentuximab vedotin with cyclophosphamide, doxorubicin, and prednisone. Both cohorts will proceed to allogeneic stem cell transplant based on their disease response.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients must weigh at least 10 kilograms at the time of the study enrollment.
* Diagnosis

Newly diagnosed patients with histologically proven mature T- and NK- cell neoplasms:

COHORT 1

* Aggressive NK cell leukemia (ICD-O code 9948/3)
* Extranodal NK/T-cell lymphoma, nasal type (ICD-O code 9719/3) COHORT 2
* Enteropathy-associated T-cell lymphoma (ICD-O code 9717/3)
* Hepatosplenic T-cell lymphoma (ICD-O code 9716/3)
* Peripheral T-cell lymphoma, non-otherwise specified (ICD-O code 9702/3)
* Angioimmunoblastic T-cell lymphoma (ICD-O code 9705/3)
* Other mature T- and NK-cell neoplasm histologies will considered after case-by-case discussion with Study Chairs and executive Vice-Chair Patients with lymphoma must have stage III or IV disease (See Appendix III for Staging).

  * Organ Function Requirements

Adequate liver function defined as:

* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age.
* ALT (SGPT) \< 3 x ULN for age.

Adequate cardiac function defined as:

* Shortening fraction of ≥ 27% by echocardiogram, or
* Ejection fraction of ≥ 50% by radionuclide angiogram.

Adequate pulmonary function defined as:

• Patients with a history of pulmonary dysfunction must have no evidence of dyspnea at rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry \> 92% while breathing room air unless current dysfunction is due to the lymphoma, in which case the patient is eligible.

Exclusion Criteria:

* Alk+ or Alk- Anaplastic Large Cell Lymphoma (ALCL)
* Patients with active CNS disease.
* Patients with stage I or stage II disease (See Appendix III for Staging).
* Patients who have received any prior cytotoxic chemotherapy for the current diagnosis of NHL.
* Previous steroid treatment and/or radiation treatment are not allowed unless they are used for emergency management. Patients who have received emergency irradiation and/or steroid therapy will be eligible only if started on protocol therapy not more than one week from the start of radiotherapy or steroids.
* Female patients who are pregnant. Pregnancy tests must be obtained in girls who are post menarchal.
* Lactating females, unless they have agreed not to breastfeed their infants.
* Patients with Down syndrome.
* Patients taking CYP3A4 substrates with narrow therapeutic indices. Patients (COHORT 2 ONLY) chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices (See Appendix V). The topical use of these medications (if applicable) is allowed.
* Patients taking CYP3A4 inhibitors. Patients (COHORT 2 ONLY) chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment (See Appendix V). The topical use of these medications (if applicable) is allowed.
* Patients taking CYP3A4 inducers. Patients (COHORT 2 ONLY) chronically receiving drugs that are known potent CYP3A4 inducers within 12 days prior to study enrollment (See Appendix V).

Where it's running

• University of Alabama
  Birmingham, Alabama, United States Recruiting
• Children's Hospital Orange County
  Orange, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• Helen De Vos
  Grand Rapids, Michigan, United States Recruiting
• New York Medical College
  Valhalla, New York, United States Recruiting
• Nationwide Children's Hospital
  Columbus, Ohio, United States Recruiting

Study contacts

• Study coordinator: Ana Xavier
• Email: axavier@peds.uab.edu
• Phone: (205) 638-6763

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.