Ann Arbor Stage III Non-Hodgkin LymphomaPhase 1NCT00740805
Veliparib, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors or Non-Hodgkin Lymphoma
A Phase 1 study testing Cyclophosphamide, Doxorubicin Hydrochloride and Laboratory Biomarker Analysis in people with Ann Arbor Stage III Non-Hodgkin Lymphoma and Ann Arbor Stage IV Non-Hodgkin Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of veliparib, cyclophosphamide, and doxorubicin hydrochloride when given together in treating patients solid tumors or non-Hodgkin lymphoma that has spread to other areas of the body or cannot be removed by surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Solid Neoplasm
- What is being tested?
- Cyclophosphamide, Doxorubicin Hydrochloride and Laboratory Biomarker Analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2008to 3 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; patients with either solid tumors or non-Hodgkin's lymphoma are eligible
- At the recommended Phase II dose level, an additional 6 to 12 patients in each group with the following criteria will be enrolled: documented breast cancer (BRCA)1/BRC2 mutation, triple-negative breast cancer defined as estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor (HER)2-negative, or patients who would benefit from a cyclophosphamide-based regimen
- On the schedule of ABT-888 given for 7 or 14 days, only patients with metastatic breast cancer will be enrolled
- Patients must be >= 4 weeks since prior chemotherapy or radiation therapy (>= 6 weeks if the last regimen included carmustine [BCNU] or mitomycin C); patients previously treated with cyclophosphamide should not be necessarily excluded
- Patients with non-Hodgkin's lymphoma that is amenable to hematopoietic stem cell transplantation with curative intent may participate only if stem cell transplant is refused or is not indicated
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
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- Life expectancy of greater than 2 months
- Hemoglobin >= 9.0 g/dL
- Absolute neutrophil count (ANC) >= 1,500/uL
- Platelets >= 100,000/uL
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal (ULN), =< 5 x ULN if known hepatic metastases
- Creatinine within normal institutional limits OR creatinine clearance >= 60 ml/min/1.73 m^2 for patients with creatinine levels above institutional normal
- Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.2 X institutional ULN
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Patients enrolled in a group where the treatment is adriamycin and cycloblastin (AC): ejection fraction >= 50% by multigated acquisition scan (MUGA) or echocardiogram
- Patients must sign informed consent
Who cannot join
- Concurrent administration of any other investigational agent(s)
- Prior high-dose therapy requiring hematopoietic stem cell transplantation
- Prior anti-cancer treatments involving radioactive pharmaceuticals
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888 and/or cyclophosphamide
- Patients receiving any medications or substances that are strong inhibitors or strong inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP 3A4), cytochrome P450, family 2, subfamily B, polypeptide 6 (2B6), cytochrome P450, family 2, subfamily C, polypeptide 9 (2C9) or cytochrome P450, family 2, subfamily C, polypeptide 19 (2C19) are prohibited; at the time of screening, if the patient is currently receiving any of the listed prohibited medication(s), the medication(s) must be discontinued for a period of no less than 7 days prior to administration of the first dose of study medication in order for the patient to meet study eligibility except for the following substance where the washout should be 6 months: amiodarone
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; New York Heart Association (NYHA) grade II or greater congestive heart failure
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- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ABT-888; these potential risks may also apply to other agents used in this study
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated; NOTE: HIV seropositive patients not receiving combination antiretroviral therapy who have cluster of differentiation (CD)4 cells >= 350/mm^3, no opportunistic infections and meet all eligibility criteria may participate in this study
- Any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain ABT-888 capsules
- Patients with gastrointestinal conditions that might predispose for drug intolerability or poor drug absorption (e.g., inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, malabsorption syndrome, active peptic ulcer disease) are excluded; subjects with ulcerative colitis, inflammatory bowel disease, or a partial or complete small bowel obstruction are also excluded
- Patients with active central nervous system (CNS) metastases are excluded
- Patients with CNS metastases that have been treated must be off steroid treatment for > 3 months, be asymptomatic and off steroid treatment prior to study enrollment
- Patients that have symptoms to suggest CNS metastases should have a brain magnetic resonance imaging (MRI) within 28 days of enrollment to confirm the absence of CNS metastases; contrast computed tomography (CT) is acceptable for patients who are unable to undergo a brain MRI
- Patients with active seizure or a history of active seizure
- Any other medical, social, or psychological condition that may significantly affect safety and/or compliance
- Patients enrolled in a group where treatment is AC: prior doxorubicin exposure of > 300 mg/m^2 or equivalent anthracycline exposure (i.e., epirubicin dose > 540 mg/m^2)
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
About this study
Official title: A Phase I Study of ABT-888 in Combination With Cyclophosphamide in Solid Tumors or Non-Hodgkin Lymphoma
This phase I trial studies the side effects and best dose of veliparib, cyclophosphamide, and doxorubicin hydrochloride when given together in treating patients solid tumors or non-Hodgkin lymphoma that has spread to other areas of the body or cannot be removed by surgery. Veliparib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving veliparib, cyclophosphamide, and doxorubicin hydrochloride may kill more cancer cells.
Read the detailed description
PRIMARY OBJECTIVES:
- Identify the maximally tolerated dose (MTD) and dose limiting toxicity (DLT) of cyclophosphamide when combined with escalating doses of ABT-888 (veliparib).
II. Identify the maximally tolerated dose (MTD) and dose limiting toxicity (DLT) of cyclophosphamide and doxorubicin (doxorubicin hydrochloride) when combined with escalating doses of ABT-888.
SECONDARY OBJECTIVES:
- Evaluate any effect of ABT-888 on the systemic clearance of parent cyclophosphamide and the dose normalized area under the curve (AUC) of 4-hydroxy (4-OH) cyclophosphamide when used in combination, using historical single-agent cyclophosphamide and 4-OH data.
II. Evaluate any effect of cyclophosphamide administration on the systemic pharmacokinetics of ABT-888 and its primary metabolite A-925088 (M8), by comparing pharmacokinetic (PK) parameters of ABT-888 on day 1 (before cyclophosphamide) and day 3 (with cyclophosphamide administration); PK samples for analysis will not be collected from patients enrolled after 2/15/2012.
III. Evaluate inhibition of poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) using an immunoassay designed to measure PAR levels in baseline and on-study peripheral blood mononuclear cells (PBMC) samples; PBMC samples for PAR analysis will not be collected from patients enrolled after 2/15/2012.
IV. Evaluate gamma H2A histone family, member X (H2AX) at baseline and on-study circulating tumor cell samples to evaluate the point of maximal deoxyribonucleic acid (DNA) damage from the combination of cyclophosphamide and doxorubicin with ABT-888.
OUTLINE: This is a dose-escalation study of veliparib and cyclophosphamide.
GROUP I: Patients receive veliparib orally (PO) every 12 hours on days 1-4 and cyclophosphamide intravenously (IV) over 60 minutes on day 3.
GROUP II: Patients receive veliparib PO every 12 hours on days 1-4, cyclophosphamide IV over 60 minutes on day 3, and doxorubicin hydrochloride IV over 15 minutes on day 3.
GROUP III: Patients receive veliparib PO every 12 hours on days 1-7, cyclophosphamide IV over 60 minutes on day 1, and doxorubicin hydrochloride IV over 15 minutes on day 1.
GROUP IV: Patients receive veliparib PO every 12 hours on days 1-14, cyclophosphamide IV over 60 minutes on day 1, and doxorubicin hydrochloride over 15 minutes on day 1.
In all groups, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
- Conditions
- Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Solid Neoplasm
- Being tested
- Cyclophosphamide, Doxorubicin Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study, Veliparib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518
Given IV
Also called 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
Correlative studies
VeliparibDrug
Also called ABT 888, ABT-888, ABT888, PARP-1 inhibitor ABT-888
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (veliparib, cyclophosphamide, doxorubicin) | Experimental | GROUP I: Patients receive veliparib PO every 12 hours on days 1-4 and cyclophosphamide IV over 60 minutes on day 3.
GROUP II: Patients receive veliparib PO every 12 hours on days 1-4, cyclophosphamide IV over 60 minutes on day 3, and doxorubicin hydrochloride IV over 15 minutes on day 3.
GROUP III: Patients receive veliparib PO every 12 hours on days 1-7, cyclophosphamide IV over 60 minutes on day 1, and doxorubicin hydrochloride IV over 15 minutes on day 1.
GROUP IV: Patients receive veliparib PO every 12 hours on days 1-14, cyclophosphamide IV over 60 minutes on day 1, and doxorubicin hydrochloride over 15 minutes on day 1.
In all groups, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Cyclophosphamide; Drug: Doxorubicin Hydrochloride; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Drug: Veliparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD, defined as the dose level that no more than 2/6 or 1/3 patients experience DLT and at least 2/3 or 3/6 patients treated with next higher dose level will have had DLT
Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Measured: 21 days
Secondary outcomes (2)
Change in pharmacokinetic parameters
A two way analysis of variance model will be used to compare the PK parameters.
Measured: Day 1, course 1 to day 1, course 2
Change in gammaH2AX levels (quantification of the time point of maximal DNA damage)
Measured: Baseline to up to day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study start18 Aug 2008
- Primary completion3 Sep 2021
- Study completion3 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ann Arbor Stage III Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark N Stein, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740805
- Sponsor's protocol ID
- NCI-2009-00262
- Other IDs
- NCI-2009-00262, CDR0000600234, 050803, 050803, 7998, P30CA072720, U01CA132194, U01CA099118
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2008
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of ABT-888 in Combination With Cyclophosphamide in Solid Tumors or Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT00740805
- Acronym / sponsor ID
- NCI-2009-00262
- Conditions
- Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Solid Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 81 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 18 Aug 2008 (actual)
- Primary completion
- 3 Sep 2021 (actual)
- Study completion
- 3 Nov 2027 (estimated)
- First posted
- 25 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I trial studies the side effects and best dose of veliparib, cyclophosphamide, and doxorubicin hydrochloride when given together in treating patients solid tumors or non-Hodgkin lymphoma that has spread to other areas of the body or cannot be removed by surgery. Veliparib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving veliparib, cyclophosphamide, and doxorubicin hydrochloride may kill more cancer cells.
Detailed description
PRIMARY OBJECTIVES:
- Identify the maximally tolerated dose (MTD) and dose limiting toxicity (DLT) of cyclophosphamide when combined with escalating doses of ABT-888 (veliparib).
II. Identify the maximally tolerated dose (MTD) and dose limiting toxicity (DLT) of cyclophosphamide and doxorubicin (doxorubicin hydrochloride) when combined with escalating doses of ABT-888.
SECONDARY OBJECTIVES:
- Evaluate any effect of ABT-888 on the systemic clearance of parent cyclophosphamide and the dose normalized area under the curve (AUC) of 4-hydroxy (4-OH) cyclophosphamide when used in combination, using historical single-agent cyclophosphamide and 4-OH data.
II. Evaluate any effect of cyclophosphamide administration on the systemic pharmacokinetics of ABT-888 and its primary metabolite A-925088 (M8), by comparing pharmacokinetic (PK) parameters of ABT-888 on day 1 (before cyclophosphamide) and day 3 (with cyclophosphamide administration); PK samples for analysis will not be collected from patients enrolled after 2/15/2012.
III. Evaluate inhibition of poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) using an immunoassay designed to measure PAR levels in baseline and on-study peripheral blood mononuclear cells (PBMC) samples; PBMC samples for PAR analysis will not be collected from patients enrolled after 2/15/2012.
IV. Evaluate gamma H2A histone family, member X (H2AX) at baseline and on-study circulating tumor cell samples to evaluate the point of maximal deoxyribonucleic acid (DNA) damage from the combination of cyclophosphamide and doxorubicin with ABT-888.
OUTLINE: This is a dose-escalation study of veliparib and cyclophosphamide.
GROUP I: Patients receive veliparib orally (PO) every 12 hours on days 1-4 and cyclophosphamide intravenously (IV) over 60 minutes on day 3.
GROUP II: Patients receive veliparib PO every 12 hours on days 1-4, cyclophosphamide IV over 60 minutes on day 3, and doxorubicin hydrochloride IV over 15 minutes on day 3.
GROUP III: Patients receive veliparib PO every 12 hours on days 1-7, cyclophosphamide IV over 60 minutes on day 1, and doxorubicin hydrochloride IV over 15 minutes on day 1.
GROUP IV: Patients receive veliparib PO every 12 hours on days 1-14, cyclophosphamide IV over 60 minutes on day 1, and doxorubicin hydrochloride over 15 minutes on day 1.
In all groups, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (veliparib, cyclophosphamide, doxorubicin) | Experimental | Drug: Cyclophosphamide, Drug: Doxorubicin Hydrochloride, Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Drug: VeliparibGROUP I: Patients receive veliparib PO every 12 hours on days 1-4 and cyclophosphamide IV over 60 minutes on day 3. GROUP II: Patients receive veliparib PO every 12 hours on days 1-4, cyclophosphamide IV over 60 minutes on day 3, and doxorubicin hydrochloride IV over 15 minutes on day 3. GROUP III: Patients receive veliparib PO every 12 hours on days 1-7, cyclophosphamide IV over 60 minutes on day 1, and doxorubicin hydrochloride IV over 15 minutes on day 1. GROUP IV: Patients receive veliparib PO every 12 hours on days 1-14, cyclophosphamide IV over 60 minutes on day 1, and doxorubicin hydrochloride over 15 minutes on day 1. In all groups, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; patients with either solid tumors or non-Hodgkin's lymphoma are eligible
- Patients must be >= 4 weeks since prior chemotherapy or radiation therapy (>= 6 weeks if the last regimen included carmustine [BCNU] or mitomycin C); patients previously treated with cyclophosphamide should not be necessarily excluded
- Patients with non-Hodgkin's lymphoma that is amenable to hematopoietic stem cell transplantation with curative intent may participate only if stem cell transplant is refused or is not indicated
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Life expectancy of greater than 2 months
Key exclusion criteria (16 listed)
- Concurrent administration of any other investigational agent(s)
- Prior high-dose therapy requiring hematopoietic stem cell transplantation
- Prior anti-cancer treatments involving radioactive pharmaceuticals
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888 and/or cyclophosphamide
- Patients receiving any medications or substances that are strong inhibitors or strong inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP 3A4), cytochrome P450, family 2, subfamily B, polypeptide 6 (2B6), cytochrome P450, family 2, subfamily C, polypeptide 9 (2C9) or cytochrome P450, family 2, subfamily C, polypeptide 19 (2C19) are prohibited; at the time of screening, if the patient is currently receiving any of the listed prohibited medication(s), the medication(s) must be discontinued for a period of no less than 7 days prior to administration of the first dose of study medication in order for the patient to meet study eligibility except for the following substance where the washout should be 6 months: amiodarone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclophosphamideAlso: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518Given IV | Drug | Treatment (veliparib, cyclophosphamide, doxorubicin) |
| Doxorubicin HydrochlorideAlso: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, AdriamycinGiven IV | Drug | Treatment (veliparib, cyclophosphamide, doxorubicin) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (veliparib, cyclophosphamide, doxorubicin) |
| Pharmacological StudyCorrelative studies | Other | Treatment (veliparib, cyclophosphamide, doxorubicin) |
| VeliparibAlso: ABT 888, ABT-888, ABT888, PARP-1 inhibitor ABT-888Given PO | Drug | Treatment (veliparib, cyclophosphamide, doxorubicin) |
Primary outcome
MTD, defined as the dose level that no more than 2/6 or 1/3 patients experience DLT and at least 2/3 or 3/6 patients treated with next higher dose level will have had DLT
Time frame: 21 days
Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
2 secondary outcomes
Change in pharmacokinetic parameters
Time frame: Day 1, course 1 to day 1, course 2
Change in gammaH2AX levels (quantification of the time point of maximal DNA damage)
Time frame: Baseline to up to day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark N Stein principal investigator
Rutgers Cancer Institute of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cyclophosphamide, Doxorubicin Hydrochloride and Laboratory Biomarker Analysis in people with Ann Arbor Stage III Non-Hodgkin Lymphoma and Ann Arbor Stage IV Non-Hodgkin Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD, defined as the dose level that no more than 2/6 or 1/3 patients experience DLT and at least 2/3 or 3/6 patients treated with next higher dose level will have had DLT (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.