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Alkylating agents

Chemotherapy + Pomalidomide for HIV-Associated Lymphoma

Phase 1
Waitlist Available
Led By Kathryn A Lurain, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must not have received prior curative-intent chemotherapy for lymphoma
Participants must be at least 18 years old with ECOG performance status <=4
Must not have
Symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Participants requiring any of the agents listed as prohibited therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 3 weeks for the first 6 cycles, every 3 months for the rest of the first year, then every 6 months for 4 years (5 years total).
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a combination of pomalidomide and chemotherapy, with or without rituximab, in adults with HIV and high-risk B-cell non-Hodgkin lymphoma. Pomalidomide boosts the immune system and helps increase important immune cells. The goal is to find the safest and most effective dose for this treatment.

Who is the study for?
Adults over 18 with HIV-associated B-cell non-Hodgkin lymphoma and high-risk features, who can take daily aspirin or substitutes, have not had prior curative-intent chemo (except as a bridge to therapy), are willing to adhere to antiretroviral therapy, and if applicable, use two forms of birth control. Must have proper organ/marrow function unless issues are due to lymphoma/HIV.
What is being tested?
The trial tests pomalidomide combined with chemotherapy drugs (cyclophosphamide, vincristine, prednisone, doxorubicin, etoposide) and possibly rituximab in people with HIV-related B-cell NHL. Participants will undergo up to six cycles of treatment involving oral medication and IV chemotherapy.
What are the potential side effects?
Potential side effects include reactions similar to those from compounds like pomalidomide or other study drugs used; these could range from allergic reactions to blood disorders. Organ inflammation or heart problems may also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not had chemotherapy aimed at curing my lymphoma.
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I am 18 or older and can at least stay in bed or a chair all day.
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My lymphoma is confirmed to be a specific type of B-cell non-Hodgkin.
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I am on medication to control my hepatitis B.
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I am willing to consistently take antiretroviral therapy.
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I can take aspirin 81mg daily or a similar blood clot prevention medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have heart failure, chest pain, or irregular heartbeats.
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I am not taking any medications that are not allowed in the study.
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I have a serious health condition that is not under control.
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My lymphoma has spread to the brain.
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I have had cancer before, but it's not one of the few exceptions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 weeks for the first 6 cycles, every 3 months for the rest of the first year, then every 6 months for 4 years (5 years total).
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 3 weeks for the first 6 cycles, every 3 months for the rest of the first year, then every 6 months for 4 years (5 years total). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
safety and tolerability
Secondary study objectives
preliminary estimates of response
progression-free survival

Side effects data

From 2015 Phase 2 trial • 36 Patients • NCT02011113
72%
NEUTROPENIA
47%
ANAEMIA
44%
THROMBOCYTOPENIA
25%
NASOPHARYNGITIS
25%
PYREXIA
25%
CONSTIPATION
22%
LYMPHOPENIA
19%
DIARRHOEA
19%
OEDEMA PERIPHERAL
19%
NAUSEA
19%
RASH
17%
LEUKOPENIA
17%
INSOMNIA
17%
MALAISE
14%
PNEUMONIA
14%
DYSGEUSIA
11%
FATIGUE
11%
EPISTAXIS
11%
DECREASED APPETITE
11%
HYPERURICAEMIA
11%
HYPOALBUMINAEMIA
11%
UPPER RESPIRATORY TRACT INFECTION
11%
HYPOKALAEMIA
8%
RASH MACULO-PAPULAR
8%
Pharyngitis
8%
HYPERGLYCAEMIA
8%
HYPOPHOSPHATAEMIA
8%
HYPOXIA
8%
ANXIETY
8%
MYALGIA
8%
HEPATIC FUNCTION ABNORMAL
8%
HERPES ZOSTER
6%
CANCER PAIN
6%
DECUBITUS ULCER
6%
PERIPHERAL SENSORY NEUROPATHY
6%
INCREASED APPETITE
6%
CYSTITIS
6%
DIABETES MELLITUS
6%
GASTROENTERITIS
6%
RESTLESSNESS
6%
HEADACHE
6%
NEUROPATHY PERIPHERAL
6%
WEIGHT INCREASED
6%
HYPOTENSION
6%
HYPOGAMMAGLOBULINAEMIA
6%
ABDOMINAL PAIN UPPER
6%
HAEMORRHOIDS
6%
ASTHMA
6%
VOMITING
6%
BRONCHITIS
6%
HYPERCALCAEMIA
6%
HYPOCALCAEMIA
6%
HYPONATRAEMIA
6%
HYPERSOMNIA
6%
DYSPHONIA
6%
PLEURAL EFFUSION
6%
HICCUPS
6%
ALANINE AMINOTRANSFERASE INCREASED
6%
ASPARTATE AMINOTRANSFERASE INCREASED
6%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
MUSCLE SPASMS
6%
WEIGHT DECREASED
6%
TREMOR
6%
HYPOTHYROIDISM
6%
SOMNOLENCE
6%
PROCTALGIA
6%
DYSPNOEA
3%
PNEUMONIA PNEUMOCOCCAL
3%
MULTI-ORGAN FAILURE
3%
PNEUMOCYSTIS JIROVECII PNEUMONIA
3%
SEPSIS
3%
INTERSTITIAL LUNG DISEASE
3%
C-REACTIVE PROTEIN INCREASED
3%
CARDIAC FAILURE
3%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
3%
URINARY RETENTION
3%
MENINGITIS
3%
SPINAL COMPRESSION FRACTURE
3%
BLOOD FIBRINOGEN DECREASED
3%
BACK PAIN
3%
SHOCK HAEMORRHAGIC
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pomalidomide Plus Dexamethasone

Awards & Highlights

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: 2/Dose ExpansionExperimental Treatment7 Interventions
Pomalidomide (at the MTD) + Prednisone, Etoposide, Doxorubicin, Vincristine and
Group II: 1/Dose EscalationExperimental Treatment7 Interventions
Pomalidomide (escalating doses) + Prednisone, Etoposide, Doxorubicin, Vincristin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pomalidomide
2011
Completed Phase 2
~1020
Doxorubicin
2012
Completed Phase 3
~8030
Cyclophosphamide
2010
Completed Phase 4
~2310
Vincristine
2003
Completed Phase 4
~2970
Prednisone
2014
Completed Phase 4
~2500
Etoposide
2010
Completed Phase 3
~2960
Rituximab
1999
Completed Phase 4
~2990

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,924 Previous Clinical Trials
41,017,931 Total Patients Enrolled
Kathryn A Lurain, M.D.Principal InvestigatorNational Cancer Institute (NCI)
3 Previous Clinical Trials
104 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05389423 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: 1/Dose Escalation, 2/Dose Expansion
Non-Hodgkin's Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT05389423 — Phase 1
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05389423 — Phase 1
~13 spots leftby Jun 2028
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