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Alkylating agents
Chemotherapy + Pomalidomide for HIV-Associated Lymphoma
Phase 1
Recruiting
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
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
Study Summary
This trial is testing a study drug (pomalidomide) in combination with chemotherapy with or without another drug (rituximab) in people with HIV-associated non-Hodgkin lymphoma.
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.Check my eligibility
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.See study design
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 belowSelect...
I have not had chemotherapy aimed at curing my lymphoma.
Select...
I am 18 or older and can at least stay in bed or a chair all day.
Select...
My lymphoma is confirmed to be a specific type of B-cell non-Hodgkin.
Select...
I am on medication to control my hepatitis B.
Select...
I am willing to consistently take antiretroviral therapy.
Select...
I can take aspirin 81mg daily or a similar blood clot prevention medication.
Timeline
Screening ~ 3 weeks3 visits
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).
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).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
safety and tolerability
Secondary outcome measures
preliminary estimates of response
progression-free survival
Side effects data
From 2015 Phase 2 trial • 36 Patients • NCT0201111372%
NEUTROPENIA
47%
ANAEMIA
44%
THROMBOCYTOPENIA
25%
PYREXIA
25%
CONSTIPATION
25%
NASOPHARYNGITIS
22%
LYMPHOPENIA
19%
DIARRHOEA
19%
OEDEMA PERIPHERAL
19%
NAUSEA
19%
RASH
17%
LEUKOPENIA
17%
INSOMNIA
17%
MALAISE
14%
DYSGEUSIA
14%
PNEUMONIA
11%
FATIGUE
11%
DECREASED APPETITE
11%
HYPERURICAEMIA
11%
HYPOALBUMINAEMIA
11%
UPPER RESPIRATORY TRACT INFECTION
11%
HYPOKALAEMIA
11%
EPISTAXIS
8%
Pharyngitis
8%
HYPERGLYCAEMIA
8%
RASH MACULO-PAPULAR
8%
HYPOPHOSPHATAEMIA
8%
HYPOXIA
8%
ANXIETY
8%
MYALGIA
8%
HEPATIC FUNCTION ABNORMAL
8%
HERPES ZOSTER
6%
WEIGHT INCREASED
6%
CANCER PAIN
6%
HYPOTENSION
6%
HYPOGAMMAGLOBULINAEMIA
6%
ABDOMINAL PAIN UPPER
6%
HAEMORRHOIDS
6%
ASTHMA
6%
VOMITING
6%
DECUBITUS ULCER
6%
BRONCHITIS
6%
HYPERCALCAEMIA
6%
HYPOCALCAEMIA
6%
HYPONATRAEMIA
6%
HYPERSOMNIA
6%
PERIPHERAL SENSORY NEUROPATHY
6%
DYSPHONIA
6%
PLEURAL EFFUSION
6%
HICCUPS
6%
ALANINE AMINOTRANSFERASE INCREASED
6%
ASPARTATE AMINOTRANSFERASE INCREASED
6%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
CYSTITIS
6%
GASTROENTERITIS
6%
DIABETES MELLITUS
6%
RESTLESSNESS
6%
INCREASED APPETITE
6%
HEADACHE
6%
NEUROPATHY PERIPHERAL
6%
MUSCLE SPASMS
6%
WEIGHT DECREASED
6%
TREMOR
6%
HYPOTHYROIDISM
6%
SOMNOLENCE
6%
PROCTALGIA
6%
DYSPNOEA
3%
SEPSIS
3%
PNEUMOCYSTIS JIROVECII PNEUMONIA
3%
MULTI-ORGAN FAILURE
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
3%
PNEUMONIA PNEUMOCOCCAL
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pomalidomide Plus Dexamethasone
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
Rituximab
1999
Completed Phase 4
~1880
Cyclophosphamide
1995
Completed Phase 3
~3780
Vincristine
2003
Completed Phase 4
~2910
Prednisone
2014
Completed Phase 4
~2370
Doxorubicin
2012
Completed Phase 3
~7940
Etoposide
2010
Completed Phase 3
~2440
Pomalidomide
2011
Completed Phase 2
~1020
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,371 Total Patients Enrolled
Kathryn A Lurain, M.D.Principal InvestigatorNational Cancer Institute (NCI)
3 Previous Clinical Trials
94 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had chemotherapy aimed at curing my lymphoma.My organs and bone marrow work well, unless it's due to my lymphoma or HIV.I am 18 or older and can at least stay in bed or a chair all day.I do not have heart failure, chest pain, or irregular heartbeats.I am not taking any medications that are not allowed in the study.I have a serious health condition that is not under control.My lymphoma is confirmed to be a specific type of B-cell non-Hodgkin.My lymphoma has spread to the brain.I am on medication to control my hepatitis B.I have specific cancer types or conditions, including a positive HIV status.I have had cancer before, but it's not one of the few exceptions.I am willing to consistently take antiretroviral therapy.I can take aspirin 81mg daily or a similar blood clot prevention medication.
Research Study Groups:
This trial has the following groups:- Group 1: 1/Dose Escalation
- Group 2: 2/Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent does the consumption of Pomalidomide endanger human health?
"The safety of pomalidomide was judged to be a 1, as there is restricted data which attests to its efficacy and risk profile."
Answered by AI
Are there any open enrollment opportunities for this research study?
"Clinicaltrials.gov confirms that this clinical trial, which was initiated on December 7th 2022 and last updated a month later in January 12th, is not actively recruiting patients. Nevertheless, there are 1827 other active trials looking for participants at the moment."
Answered by AI
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