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Monoclonal Antibodies

Chemoimmunotherapy + Stem Cell Transplant for NK T-cell Lymphoma/Leukemia

Phase < 1

Recruiting

Research Sponsored by New York Medical College

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with lymphoma must have stage III or IV disease

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

Must not have

Patients with active CNS disease

Alk+ or Alk- Anaplastic Large Cell Lymphoma (ALCL)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 year

Awards & highlights

Approved for 60 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is studying two different chemotherapy combinations followed by stem cell transplant in treating patients with newly diagnosed stage III-IV non-Hodgkin lymphoma or leukemia.

Who is the study for?

This trial is for children, adolescents, and young adults with advanced T-cell or NK-cell leukemia/lymphoma. They must weigh at least 10 kg, have good heart and lung function, and not be pregnant or breastfeeding. Prior chemotherapy for the current diagnosis disqualifies participation.

What is being tested?

The study tests two chemoimmunotherapy regimens: modified SMILE plus pembrolizumab (Cohort 1) for NK cell cancers; PRX/BV combined with other drugs (Cohort 2) for peripheral T-cell lymphomas. Successful participants will proceed to allogeneic stem cell transplant.

What are the potential side effects?

Potential side effects include immune system suppression leading to increased infection risk, nausea, hair loss from chemotherapy, allergic reactions to medications used in treatment regimens, and complications related to stem cell transplantation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lymphoma is at an advanced stage (III or IV).

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I have been recently diagnosed with a specific type of blood cancer.

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My liver is functioning well, with normal bilirubin and ALT levels.

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I weigh at least 10 kilograms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active brain or spinal cord disease.

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My condition is ALK positive or negative Anaplastic Large Cell Lymphoma.

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I am currently taking medication that affects liver enzyme levels.

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I am on medication that is sensitive to changes in my body's enzyme levels.

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I am currently pregnant.

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I am currently taking medication that affects liver enzyme levels.

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My cancer is in the early stages (stage I or II).

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I have received chemotherapy for my current non-Hodgkin lymphoma diagnosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

overall response rate

Secondary study objectives

event free survival

Side effects data

From 2016 Phase 2 trial • 303 Patients • NCT02004262

93%

Chills

67%

Pyrexia

51%

Nausea

44%

Fatigue

38%

Abdominal pain

37%

Vomiting

24%

Constipation

23%

Aspartate aminotransferase increased

22%

Headache

21%

Diarrhoea

21%

Anaemia

21%

Hypotension

18%

Decreased appetite

18%

Alanine aminotransferase increased

17%

Tachycardia

15%

Blood alkaline phosphatase increased

15%

Hypertension

15%

Back pain

13%

Myalgia

11%

Hypokalaemia

11%

Thrombocytopenia

11%

Dizziness

10%

Hypoalbuminaemia

Pain

Hyponatraemia

Pain in extremity

Dyspnoea

Blood albumin decreased

Dehydration

Oedema peripheral

Hypomagnesaemia

Weight decreased

Sinus tachycardia

Dry mouth

Disease progression

Flatulence

Arthralgia

Pruritus

Cough

Insomnia

Anxiety

Abdominal Pain

Abdominal pain upper

Abdominal distension

Hypophosphataemia

Lymphocyte count decreased

Blood creatinine increased

Blood sodium decreased

Rash

Night sweats

Confusional state

Ascites

Asthenia

Hyperglycaemia

Blood bilirubin increased

Pulmonary embolism

Hypoxia

Bile duct obstruction

Urinary tract infection

Gastrointestinal haemorrhage

Small intestinal obstruction

Gastrooesophageal reflux disease

Leukocytosis

Obstruction gastric

Blood glucose decreased

Colitis

Oesophagitis

Cholangitis

Death

Pneumonia

Portal vein thrombosis

Bacteraemia

Lung infection

Influenza

Cerebrovascular accident

Hypercalcaemia

Orthostatic hypotension

Venous thrombosis

Venous thrombosis limb

Atrial fibrillation

Cardiac arrest

Fall

Oliguria

Mental status changes

Delirium

Hyperkalaemia

Neutropenia

Deep vein thrombosis

Neuropathy peripheral

Erythema

Encephalopathy

Respiratory failure

Pneumonia klebsiella

100%

80%

60%

40%

20%

Study treatment Arm

Pooled Cohort: CRS-207

Pooled Cohort: Cy/GVAX + CRS-207

Pooled Cohort: Chemotherapy

Awards & Highlights

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment5 Interventions

Patients with stage III or IV peripheral T-cell lymphoma-NOS, angioimmunoblastic T-cell lymphoma, hepatosplenic T-cell lymphoma, or enteropathy-associated T-cell lymphoma (other histologies will be considered after case-by-case discussion with Study Chairs and Executive Vice-Chairs). Chemotherapy Regimen: Cycle 1 \& 2: Pralatrexate Days 1, 8, and 15, cyclophosphamide Day 1, DOXOrubicin Day 1, predniSONE days 1-5 Cycle 3 \& 5: Brentuximab vedotin Day 1, cyclophosphamide Day 1, DOXOrubicin Day 1, predniSONE days 1-5 Cycle 4 \& 6: Pralatrexate Days 1, 8, and 15, cyclophosphamide Day 1, DOXOrubicin Day 1, predniSONE days 1-5 Allogeneic Stem Cell Transplant if donor available and not in PD.

Group II: Cohort 1Experimental Treatment5 Interventions

Patients with aggressive NK cell leukemia or stage III or IV extranodal NK/T-cell lymphoma, nasal type. Chemotherapy Regimen: mSMILE: Methotrexate Day 1, Ifosfamide Days 2-4, Dexamethasone Days 2-4, Etoposide Days 2-4, calaspargase pegol Day 8. For patients in CR and no available allogeneic SCT can receive up to 2 additional cycles of mSMILE. Pembrolizumab: For patients in PR/MR/NR/PD after 2 cycles of mSMILE. Allogeneic Stem Cell Transplant if donor available and not in PD.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methotrexate

FDA approved

Ifosfamide

FDA approved

Dexamethasone

FDA approved

Etoposide

FDA approved

Cyclophosphamide

FDA approved

Doxorubicin

FDA approved

Prednisone

FDA approved

Brentuximab vedotin

FDA approved

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

New York Medical CollegeLead Sponsor

71 Previous Clinical Trials

6,114 Total Patients Enrolled

University of Alabama at BirminghamOTHER

1,656 Previous Clinical Trials

2,444,335 Total Patients Enrolled

Mitchell Cairo, MDStudy Director - New York Medical College

Fort Washington Medical Center, Holy Cross Germantown Hospital, Holy Cross Hospital of Silver Spring, Inova Alexandria Hospital, Inova Fairfax Hospital, MedStar Southern Maryland, Said M Ali Mdpc, Washington Adventist Hospital

University Of Cairo (Medical School)

Aultman Hospital (Residency)

13 Previous Clinical Trials

296 Total Patients Enrolled